BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors

This study aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early signs of fighting cancer in people with certain advanced or metastatic solid tumors.

Key details of the study include:

• The study is expected to last about 36 months.
• Participants will receive treatment until they either no longer benefit from the treatment, experience side effects that are too severe, or choose to stop participating.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor; Advanced Solid Tumor; Metastatic Solid Tumor
• Intervention / Treatment: Drug: Tislelizumab; Drug: BGB-A3055; Drug: Chemotherapy

Detailed Description

The primary objective of the study is to assess the safety and tolerability of BGB-A3055 alone or in combination with Tislelizumab during dose escalation and to determine the recommended dose for expansion. During dose expansion, the primary objective will be to assess preliminary anti-tumor activity and further characterize the safety of the recommended dose for expansion.

. Around 318 participants will be enrolled in this study, and they will be assigned to different treatment groups. Both the participants and their doctors will be aware of which treatment group they are assigned to throughout the study.

The treatments, BGB-A3055 alone or in combination with Tislelizumab, will be administered intravenously to evaluate their safety and determine the highest dose that can be tolerated by participants. The study will be conducted at multiple medical centers worldwide. The expected duration of participation in this study is two years. Treatment will continue until participants no longer receive any benefits from the drugs, experience excessive side effects, or decide to withdraw their consent.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris OBrien Lifehouse
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Centre South Brisbane
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research
• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201801
      • Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch
  • Shanxi
    • Changzhi, Shanxi, China, 046099
      • Changzhi Peoples Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine
• France
  • Bordeaux, France, 33000
    • Centre de Lutte Contre Le Cancer Institut Bergonie
  • Paris, France, 75005
    • Institut Curie
  • SaintHerblain, France, 44805
    • Ico Site Rene Gauducheau
• South Korea
  • Gyeonggi-do
    • BundangGu SeongnamSi, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital
    • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
      • Asan Medical Center
• United States
  • Florida
    • Orlando, Florida, United States, 32804-4603
      • Advent Health Cancer Institute
  • Iowa
    • Iowa City, Iowa, United States, 52242-1009
      • University of Iowa Hospitals and Clinics
  • New Jersey
    • Hackensack, New Jersey, United States, 07601-2191
      • John Theurer Cancer Center Hackensack University Medical Center
  • Texas
    • Houston, Texas, United States, 77030-4009
      • The University of Texas MD Anderson Cancer Center
    • Irving, Texas, United States, 75039-2743
      • NEXT Dallas
  • Washington
    • Seattle, Washington, United States, 98109-4433
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age≥18 years on the day of signing the informed consent form (ICF) (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older).
2. All participants are also required to demonstrate an ECOG Performance Status score of ≤1 within 3 days before the first dose of study drug(s) and have adequate organ function.
3. Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received adequate available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received any prior therapy targeting CCR8.
4. >=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5. Participants should be able to provide archival tumor tissue samples (as block or unstained slides) or fresh biopsy if there is no archival tissue at baseline. For selected cohorts, participants should be willing to provide post-treatment fresh biopsy at specified timepoints.
6. Females of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 120 days after the last dose of BGB-A3055 or tislelizumab (whichever is later), or up to 9 months after the last dose of chemotherapy, whichever is later. Females of childbearing potential must also have a negative urine or serum pregnancy test result ≤ 7 days before the first dose of study drug(s).

Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
2. Active autoimmune diseases or history of autoimmune diseases that may relapse
3. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).

4. Participants with hepatitis B infection with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL). Participants with active hepatitis C, and participants with HIV infection.

   Note: Participants with chronic hepatitis B infection or resolved hepatitis B infection (HBV DNA < 500 IU/mL or < 2500 copies/mL) and considered stable are eligible. Participants with a negative HCV antibody test result at screening or a positive HCV antibody test result followed by a negative HCV RNA test result at screening are eligible to participate. Participants with treated HIV infection may be included if certain criteria are met.

5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.
6. Grade 3 immune-mediated adverse events on prior immune-oncology agent.
7. Cardiovascular risk factors, including but not limited to pulmonary embolism ≤ 28 days or history of acute myocardial infarction or heart failure ≤ 6 months before the first dose of study drug(s).
8. Uncontrolled diabetes.

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy); Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels.	Drug: BGB-A3055; Administered intravenously
Experimental: Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab); Different groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels.	Drug: Tislelizumab; Administered intravenously; Other Names: BGB-A317; Drug: BGB-A3055; Administered intravenously
Experimental: Phase 1b (Dose Expansion): Participants will receive the recommended dose for expansion (RDFE) of BGB-A3055 in combination with tislelizumab with or without chemotherapy to provide additional information on the safety, tolerability, and potential benefits of the recommended dose.	Drug: Tislelizumab; Administered intravenously; Other Names: BGB-A317; Drug: BGB-A3055; Administered intravenously; Drug: Chemotherapy; Administered in accordance with relevant local guidelines and/or prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: Number of participants with adverse events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the American Society for Transplantation and Cellular Therapy [ASTCT] consensus grading system for cytokine release syndrome [CRS]), and including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.	Up to 2 Years
Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055	MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 30%. MAD is defined as the highest dose administered.	Up to 2 Years
Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055 alone or in combination with tislelizumab	The RDFEs of BGB-A3055, alone or in combination with tislelizumab will be determined based on biological effectiveness taking preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration.	Up to 2 Years
Phase 1b (Dose Expansion): Objective Response Rate (ORR)	ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Up to 2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of BGB-A3055 at specified time points		Up to 2 Years
Number of participants with anti-drug antibodies (ADAs) against BGB-A3055		Up to 2 Years
Phase 1a: ORR	ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Up to 2 Years
Time to Response (TTR)	Defined as the time from the date of the first administration of study drug(s) to the first determination of an objective response.as determined from tumor assessments by the investigators per RECIST v1.1.	Up to 2 Years
Duration of Response (DOR)	Defined as the time from the first determination of an objective response to the time of first documentation of radiographic progression, as determined from tumor assessments by the investigators per RECIST v1.1, or death from any cause, whichever comes first.	Up to 2 Years
Disease Control Rate (DCR)	Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease as determined from tumor assessments by the investigators per RECIST v1.1.	Up to 2 Years
Clinical Benefit Rate (CBR)	Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or durable stable disease (stable disease for at least 24 weeks) as determined from tumor assessments by the investigators per RECIST v1.1.	Up to 2 Years
Phase 1b: Progression-Free Survival (PFS)	Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as determined from tumor assessments by investigators per RECIST v1.1.	Up to 2 Years
Phase 1b: Number of participants with adverse events (AEs)	Number of participants with TEAEs and SAEs graded according to the NCI-CTCAE version 5.0 and the ASTCT consensus grading system for CRS, and including findings from laboratory assessments, ECGs, and physical examinations.	Up to 2 Years
Phase 1b: Association of CCR8 expression with clinical efficacy	Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab with or without chemotherapy, and their association with clinical efficacy.	Up to 2 Years
Phase 1b: Association of PD-L1 expression with clinical efficacy	Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab with or without chemotherapy, and their association with clinical efficacy.	Up to 2 Years

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Actual): January 27, 2026
• Study Completion (Actual): January 27, 2026

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Monoclonal antibody; PD1; Metastatic Solid Tumor; Metastatic cancer; Tislelizumab; Advanced solid tumors; CCR8; Safety monitoring; BGB-A3055; Preliminary antitumor activity
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Therapeutics; Drug Therapy; tislelizumab
• Other Study ID Numbers: BGB-A317-A3055-101; 2023-505322-34-00 (Ctis: CTIS); CTR20241681 (Other Identifier: ChinaDrugTrials)

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