Study of Surzebiclimab (BGB-A425) and Alcestobart (LBL-007) in Combination With Tislelizumab in Advanced Solid Tumors

March 13, 2026 updated by: BeiGene

Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Various Combinations of BGB-A425 and LBL-007 With Tislelizumab in Patients With Advanced Solid Tumors

This was an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of surzebiclimab (BGB-A425) and/or alcestobart (LBL-007) with tislelizumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Blocking antibodies targeting programmed cell death protein-1 (PD-1) have achieved remarkable results in the treatment of many types of tumors. However, based upon the rate of primary and secondary resistance to PD-1 blockade, it was apparent that additional immuno-regulatory mechanism(s) underlie tumor immune escape. Indeed, research shows that the T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) pathway cooperates with PD-1 to maximize the suppression of effector tumor infiltrating lymphocytes (TILs) as well as promote resistance to anti-PD-1 therapy. Therefore, TIM-3 represents an ideal target with the potential to significantly improve and/or extend the therapeutic benefit of anti-PD-1 therapy to a greater number of participants.

TIM-3, Lymphocyte activation gene-3 (LAG-3), and PD-1 function as immune checkpoint receptors in the overlapping regulation of immune tolerance and have been shown to be co-overexpressed on the TILs from the participant samples of various solid tumors. Furthermore, emerging clinical data and preclinical data demonstrate co-expression of TIM-3, LAG-3, PD-1 often yield T cells exhausted immunophenotype (i.e., cytokine expression, proliferation etc.). Cancer cells take advantage of PD-1, TIM-3, and LAG-3 in inhibiting immune cells' function, and escape the immune surveillance. Based upon the overlapping expression profiles and immuno-regulatory functions, TIM-3 and LAG-3 mediated adaptive resistance, there was strong scientific rationale that simultaneous targeting of these checkpoint blockers, could potentially increase therapeutic benefit and might help to overcome the resistance arising due to anti-PD-(L)-1 therapy. Hence, this study evaluated the safety and preliminary efficacy of surzebiclimab (anti TIM-3), alcestobart (Anti-LAG-3) in combination with tislelizumab (anti PD-1) in patients with advanced solid tumors.

This was an open-label, multicenter, nonrandomized Phase 1 and Phase 2 clinical trial. Phase 1 determined the recommended phase 2 dose (RP2D) for the combination of surzebiclimab and tislelizumab. Phase 2 safety lead-in determined the RP2D for the combination of surzebiclimab, tislelizumab and/or alcestobart. Phase 2 dose expansion continued to evaluate the safety but also focus on the efficacy of the doublet or triplet treatment combination in select tumor types.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, NSW 2170
        • Sydney Southwest Private Hospital
    • Queensland
      • Birtinya, Queensland, Australia, QLD 4575
        • Sunshine Coast Hospital and Health Service
      • Southport, Queensland, Australia, QLD 4215
        • Gold Coast University Hospital
    • South Australia
      • Elizabeth Vale, South Australia, Australia, SA 5112
        • Lyell McEwin Hospital
      • North Adelaide, South Australia, Australia, SA 5006
        • Calvary North Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, VIC 3128
        • Box Hill Hospital
      • Malvern, Victoria, Australia, VIC 3144
        • Cabrini Research and Education Institute
      • Melbourne, Victoria, Australia, VIC 3000
        • Peter MacCallum Cancer Centre
      • St Albans, Victoria, Australia, VIC 3021
        • Western Health Sunshine Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, WA 6009
        • Linear Clinical Research
      • Nedlands, Western Australia, Australia, WA 6009
        • Hollywood Private Hospital
  • France
      • Bordeaux, France, 33000
        • Centre de Lutte Contre Le Cancer Institut Bergonie
      • Caen, France, 14000
        • Centre de Lutte Contre le Cancer François Baclesse
      • Paris, France, 75005
        • Institut Curie Paris
  • Italy
      • Bologna, Italy, 40138
        • Irccs Azienda Ospedaliero Universitaria Bologna
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Torino, Italy, 10060
        • Istituto Di Candiolo Irccs
  • South Korea
      • Suwon, South Korea, 16499
        • Ajou University Hospital
    • Chungcheongbukdo
      • SeowonGu CheongjuSi, Chungcheongbukdo, South Korea, 28644
        • Chungbuk National University Hospital
    • Gyeonggi-do
      • PaldalGu SuwonSi, Gyeonggi-do, South Korea, 16247
        • The Catholic University of Korea, St Vincents Hospital
    • Incheon Gwang'Yeogsi
      • NamdongGu, Incheon Gwang'Yeogsi, South Korea, 21565
        • Gachon University Gil Medical Center
    • Seoul Teugbyeolsi
      • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St Marys Hospital
      • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center
    • Ulsan Gwang'Yeogsi
      • Donggu, Ulsan Gwang'Yeogsi, South Korea, 44033
        • Ulsan University Hospital
  • Spain
      • Barcelona, Spain, 08908
        • Institut Catala Doncologia
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28050
        • Hospital Universitario Hm Madrid Sanchinarro
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
  • United States
    • California
      • Orange, California, United States, 92868-3201
        • Chao Family Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045-2517
        • University of Colorado Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1443
        • University of Chicago Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-7001
        • University of Kentucky Markey Cancer Center
    • New York
      • New York, New York, United States, 10065-4870
        • Weill Cornell Medical College Newyork Presbyterian Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514-4220
        • University of North Carolina At Chapel Hill
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2434
        • Fox Chase Cancer Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • The University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229-4427
        • UT Health San Antonio Mays Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0817
        • University of Virginia
      • Fairfax, Virginia, United States, 22031-4867
        • Schar Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Participants were aged >=18 years.
  • Adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) performance status <=1.
  • Must have been able to provide a recently obtained archival tumor tissue or fresh tumor biopsy.
  • The phase 1 dose escalation and phase 2 safety lead-in enrolled participants with histologically/cytologically confirmed advanced/metastatic solid tumors who had previously received standard systemic therapy per local guidelines, unless it was not available, not tolerated or determined not appropriate based on investigators judgement, and had at least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • The phase 2 dose expansion enrolled participants with recurrent/metastatic HNSCC (Cohorts 1 and 4) and advanced/metastatic NSCLC (Cohorts 2 and 5), with disease progression that occurred >=10 weeks from the initiation of anti-PD-1/PD-L1 treatment for locally advanced or metastatic disease and had at least 1 measurable lesion outside of the central nervous system per RECIST v1.1.

Key Exclusion Criteria:

  • A history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Active autoimmune disease or a history of autoimmune diseases that might relapse or a history of life-threatening toxicity related to prior immune therapy.
  • Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication <=14 days before administration of study drug.
  • A history of interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases.
  • Prior therapy targeting TIM-3 and/or LAG-3.
  • The phase 2 dose expansion NSCLC cohorts excluded participants with known sensitizing epidermal growth factor receptor (EGFR) mutation, v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutation, anaplastic lymphoma kinase (ALK) fusion, or c-ros oncogene 1 (ROS1) fusion.

NOTE: Other protocol defined Inclusion/Exclusion criteria might apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 2 Milligrams (mg) + Tislelizumab
Participants received surzebiclimab 2 mg intravenous (IV) infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Alcestobart
Human anti LAG-3 antibody
Other Names:
  • LBL-007
Experimental: Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Alcestobart
Human anti LAG-3 antibody
Other Names:
  • LBL-007
Experimental: Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab
Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Alcestobart
Human anti LAG-3 antibody
Other Names:
  • LBL-007
Experimental: Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + BGB-A425 + Tislelizumab
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Alcestobart
Human anti LAG-3 antibody
Other Names:
  • LBL-007
Experimental: Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Drug: Alcestobart
Human anti LAG-3 antibody
Other Names:
  • LBL-007
Experimental: Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab
Participants received alcestobart 900 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Drug: Alcestobart
Human anti LAG-3 antibody
Other Names:
  • LBL-007
Experimental: Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab
Participants with head and neck squamous cell carcinoma (HNSCC) received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab
Participants with non-small cell lung cancer (NSCLC) received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Experimental: Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Drug: Alcestobart
Human anti LAG-3 antibody
Other Names:
  • LBL-007
Experimental: Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
Drug: Tislelizumab
Humanized, IgG4-variant monoclonal antibody against PD-1
Other Names:
  • BGB-A317
Drug: Surzebiclimab
Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3
Other Names:
  • BGB-A425
Drug: Alcestobart
Human anti LAG-3 antibody
Other Names:
  • LBL-007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 30 days after last dose of study drug (maximum treatment duration: up to 32.7 months)
An Adverse Event (AE) was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Up to 30 days after last dose of study drug (maximum treatment duration: up to 32.7 months)
Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Surzebiclimab in Combination With Tislelizumab
Time Frame: Up to 28 days
The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 1, therefore the MAD was reported.
Up to 28 days
Phase 1: Recommended Phase 2 Dose (RP2D) of Surzebiclimab in Combination With Tislelizumab
Time Frame: Up to 28 days
The RP2D or recommended dose for expansion of the combination treatment was determined based upon the MTD or MAD, and also considered the long-term tolerability, PK, efficacy, and any other relevant data as available.
Up to 28 days
Phase 2 (Safety Lead-In): Number of Participants With TEAEs and SAEs
Time Frame: Up to 30 days after last dose of study drug (maximum duration of treatment: up to 19.6 months in Cohort A and up to 21.5 months in Cohort B)
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Up to 30 days after last dose of study drug (maximum duration of treatment: up to 19.6 months in Cohort A and up to 21.5 months in Cohort B)
Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Tislelizumab
Time Frame: Up to 21 days
The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 2, therefore the MAD was reported.
Up to 21 days
Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Surzebiclimab and Tislelizumab
Time Frame: Up to 21 days
The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 2, therefore the MAD was reported.
Up to 21 days
Phase 2 (Safety Lead-In): RP2D of Alcestobart in Combination With Surzebiclimab and Tislelizumab
Time Frame: Up to 21 days
The RP2D or recommended dose for expansion of the combination treatment was determined based upon the MTD or MAD, and also considered the long-term tolerability, PK, efficacy, and any other relevant data as available.
Up to 21 days
Phase 2 (Dose Expansion): Overall Response Rate (ORR)
Time Frame: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to11.3 months, Cohort 5: up to 15.9 months
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to11.3 months, Cohort 5: up to 15.9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Overall Response Rate (ORR)
Time Frame: Maximum time on study: up to 57.5 months
ORR was defined as the percentage of participants who had CR or PR. Per RECIST v.1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Maximum time on study: up to 57.5 months
Phase 2 (Safety Lead- In): Overall Response Rate (ORR)
Time Frame: Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months
ORR was defined as the percentage of participants who had CR or PR. Per RECIST v.1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months
Phase 1: Disease Control Rate (DCR)
Time Frame: Maximum time on study: up to 57.5 months
DCR was defined as the percentage of participants with a best overall response (BOR) of CR, PR, or stable disease (SD), per RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Maximum time on study: up to 57.5 months
Phase 2 (Safety Lead-In): Disease Control Rate (DCR)
Time Frame: Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months
DCR was defined as the percentage of participants with a BOR of CR, PR, or SD, per RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months
Phase 2 (Dose Expansion): Disease Control Rate (DCR)
Time Frame: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
DCR was defined as the percentage of participants with a BOR of CR, PR, or SD, per RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
Phase 2 (Dose Expansion): Duration of Response (DOR)
Time Frame: From the first determination of an overall response until PD or death, whichever came first (Maximum time on study [Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months])
DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
From the first determination of an overall response until PD or death, whichever came first (Maximum time on study [Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months])
Phase 2 (Dose Expansion): Progression Free Survival (PFS)
Time Frame: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
Progression free survival was defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of disease progression assessed by investigator or death, whichever occurred first as determined from investigator derived tumor assessments per RECIST 1.1. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Surzebiclimab
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI; within 30 minutes), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI. Cycle 1 was 28 days and Cycle 5 was 21 days.
The maximum observed plasma concentration of surzebiclimab was measured in Cycle 1 and Cycle 5.
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI; within 30 minutes), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI. Cycle 1 was 28 days and Cycle 5 was 21 days.
Phase 2 (Dose Expansion): Cmax of Surzebiclimab
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Phase 1: Minimum Observed Plasma Concentration (Cmin) of Surzebiclimab
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI (Cycle 1 was 28 days; Cycle 2 and thereafter were 21 days)
Cmin of surzebiclimab was determined.
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI (Cycle 1 was 28 days; Cycle 2 and thereafter were 21 days)
Phase 2 (Dose Expansion): Cmin of Surzebiclimab
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Surzebiclimab
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI (Cycle 1 was28 days; Cycle 2 and thereafter were 21 days)
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI (Cycle 1 was28 days; Cycle 2 and thereafter were 21 days)
Phase 2 (Dose Expansion): Tmax of Surzebiclimab
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Phase 1: Half-Life (t1/2) of Surzebiclimab
Time Frame: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)
Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)
Phase 2 (Dose Expansion): T1/2 of Surzebiclimab
Time Frame: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Phase 1: Area Under Curve From 0 to 21 Days (AUC0-21d) of Surzebiclimab
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (Cycle 1 was 28 days; Cycle 2 and thereafter were 21 days)
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (Cycle 1 was 28 days; Cycle 2 and thereafter were 21 days)
Phase 2 (Dose Expansion): AUC0-21d of Surzebiclimab
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle duration= 21 days)
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle duration= 21 days)
Phase 1: Clearance (CL/F) of Surzebiclimab
Time Frame: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)
Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)
Phase 2 (Dose Expansion): CL/F of Surzebiclimab
Time Frame: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Phase 1: Volume of Distribution (Vz/F) of Surzebiclimab
Time Frame: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)
Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)
Phase 2 (Dose Expansion): Vz/F of Surzebiclimab
Time Frame: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Vz/F of surzebiclimab was determined.
Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Phase 2 (Safety Lead-In): Cmax of Alcestobart
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Phase 2 (Safety Lead-In): Cmin of Alcestobart
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Cmin of alcestobart was determined.
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Phase 2 (Safety Lead-In): Tmax of Alcestobart
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Phase 2 (Safety Lead-In): t1/2 of Alcestobart
Time Frame: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Phase 2 (Safety Lead-In): AUC0-21d of Alcestobart
Time Frame: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)
Phase 2 (Safety Lead-In): CL/F of Alcestobart
Time Frame: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Phase 2 (Safety Lead-In): Vz/F of Alcestobart
Time Frame: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI
Phase 1: Serum Concentrations of Tislelizumab
Time Frame: Pre-dose and EOI (within 30 minutes) on Cycle 1 Day 8 and Cycle 5 Day 1, and pre-dose on Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 25 (Cycle 1 was 28 days, Cycle 2 and thereafter were 21 days)
Serum concentrations of tislelizumab were measured using an enzyme-linked immunosorbent assay (ELISA).
Pre-dose and EOI (within 30 minutes) on Cycle 1 Day 8 and Cycle 5 Day 1, and pre-dose on Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 25 (Cycle 1 was 28 days, Cycle 2 and thereafter were 21 days)
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Time Frame: Pre-dose on Day 1 of Cycles 1, 2, 5, 6, 9, 13, 17, 25 and at EOI (within 30 minutes) on Day 1 of Cycles 1 and 5 (each cycle was 21 days)
Serum concentrations of tislelizumab were measured using an enzyme-linked immunosorbent assay (ELISA).
Pre-dose on Day 1 of Cycles 1, 2, 5, 6, 9, 13, 17, 25 and at EOI (within 30 minutes) on Day 1 of Cycles 1 and 5 (each cycle was 21 days)
Phase 1: Number of Participants With Anti-Drug Antibodies (ADA) to Surzebiclimab
Time Frame: Maximum time on study: up to 57.5 months
Immunogenic responses to surzebiclimab included: treatment emergent, treatment-induced and treatment boosted anti-drug antibodies (ADA) and neutralizing antibody (NAb) positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the Baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive Nab at any time including baseline and/or after drug administration.
Maximum time on study: up to 57.5 months
Phase 2 (Safety Lead-In) Cohort B: Number of Participants With Anti-Drug Antibodies to Surzebiclimab
Time Frame: Maximum time on study in Cohort B: up to 21.5 months
Immunogenic responses to surzebiclimab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Maximum time on study in Cohort B: up to 21.5 months
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Surzebiclimab
Time Frame: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
Immunogenic responses to surzebiclimab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Alcestobart
Time Frame: Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months
Immunogenic responses to alcestobart included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months
Phase 2 (Dose Expansion) Cohorts 4 and 5: Number of Participants With Anti-Drug Antibodies to Alcestobart
Time Frame: Maximum time on study: Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
Immunogenic responses to alcestobart included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Maximum time on study: Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
Phase 1: Number of Participants With Anti-Drug Antibodies to Tislelizumab
Time Frame: Maximum time on study: up to 57.5 months
Immunogenic responses to tislelizumab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Maximum time on study: up to 57.5 months
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Tislelizumab
Time Frame: Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months
Immunogenic responses to alcestobart included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Tislelizumab
Time Frame: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
Immunogenic responses to tislelizumab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months
Phase 2 (Dose Expansion): Number of Participants With TEAEs and SAEs
Time Frame: Up to 30 days after last dose of study drug (maximum treatment duration: Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months)
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Up to 30 days after last dose of study drug (maximum treatment duration: Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeiGene

Investigators

  • Study Director: Study Director, BeiGene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2018

Primary Completion (Actual)

February 6, 2025

Study Completion (Actual)

February 6, 2025

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-900-102
  • U1111-1278-0027 (Other Identifier: UTN Number)
  • 2022-500694-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Locally Advanced or Metastatic Solid Tumors for Phase 1, Dose Escalation and Phase 2 Safety Lead-in

Clinical Trials on Tislelizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe