A Study Investigating the Efficacy and Safety of Alcestobart (LBL-007) Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer

July 21, 2026 updated by: BeiGene

A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

This is a Phase 1b/2 study to investigate the efficacy and safety of alcestobart (LBL-007) plus tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine, and alcestobart in combination with bevacizumab plus fluoropyrimidine versus bevacizumab plus fluoropyrimidine to participants with colorectal cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

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
      • Blacktown, New South Wales, Australia, NSW 2148
        • Blacktown Cancer and Haematology Centre
      • Orange, New South Wales, Australia, NSW 2800
        • Orange Health Service (Central West Cancer Care Centre)
      • Wagga Wagga, New South Wales, Australia, NSW 2650
        • Riverina Cancer Care Centre
      • Waratah, New South Wales, Australia, NSW 2298
        • Calvary Mater Newcastle
    • Queensland
      • Benowa, Queensland, Australia, QLD 4217
        • Pindara Private Hospital
    • Victoria
      • Clayton, Victoria, Australia, VIC 3168
        • Monash Health
      • Melbourne, Victoria, Australia, VIC 3004
        • The Alfred Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, WA 6150
        • St John of God, Murdoch
      • Nedlands, Western Australia, Australia, WA 6009
        • One Clinical Research
  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 102218
        • Beijing Tsinghua Changgung Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Quanzhou, Fujian, China, 362000
        • Quanzhou First Affliated Hospital of Fujian Medical University
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhujiang Hospital of Southern Medical University
      • Shantou, Guangdong, China, 515041
        • The First Affiliated Hospital of Shantou University Medical College
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Nantong, Jiangsu, China, 215124
        • Nantong First Peoples Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First hospital of Jilin University
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Jining, Shandong, China, 272000
        • Jining No1 Peoples Hospital West Branch
      • Linyi, Shandong, China, 276000
        • Linyi Peoples Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200123
        • Shanghai East Hospital Branch Hospital
      • Shanghai, Shanghai Municipality, China, 200000
        • Renji Hospital Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, China, 300121
        • Tianjin Union Medical Center (Nankai University Affiliated Hospital)
    • Xinjiang
      • Karamay, Xinjiang, China, 834009
        • Karamay Central Hospital of Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • The Xinjiang Uygur Autonomous Region Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • the Second Affiliated Hospital of Zhejiang University School of Medicine
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Pan American Oncology Trials, LLC
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508-2974
        • Alaska Oncology and Hematology, LLC
    • Arizona
      • Gilbert, Arizona, United States, 85234-2165
        • Banner MD Anderson Cancer Center
    • California
      • Cerritos, California, United States, 90703
        • Helios Clinical Research
      • Los Angeles, California, United States, 90067-2011
        • Valkyrie Clinical Trials
      • Los Angeles, California, United States, 90089-1019
        • Usc Norris Comprehensive Cancer Center (Nccc)
      • Los Angeles, California, United States, 90095-3075
        • UCLA Hematologyoncology
      • Newport Beach, California, United States, 92663-4162
        • Hoag Memorial Presbyterian
      • Vallejo, California, United States, 94589-2441
        • Kaiser Permanente Northern California
    • Florida
      • Jacksonville, Florida, United States, 32207-8432
        • Baptist MD Anderson Cancer Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology and Hematology
    • Kentucky
      • Lexington, Kentucky, United States, 40536-7001
        • University of Kentucky Markey Cancer Center
      • Lexington, Kentucky, United States, 40503-1466
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40217-1395
        • Norton Cancer Institute
    • Louisiana
      • Covington, Louisiana, United States, 70433-7512
        • Pontchartrain Cancer Center
      • New Orleans, Louisiana, United States, 70121-2429
        • Ochsner Clinic Foundation
    • Missouri
      • St Louis, Missouri, United States, 63110-1010
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, United States, 59102-6746
        • St Vincent Frontier Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169-3321
        • Comprehensive Cancer Centers of Nevada
      • Reno, Nevada, United States, 89511-2250
        • Cancer Care Specialists
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102-4517
        • University of New Mexico Comprehensive Cancer Center
    • New York
      • Mineola, New York, United States, 11501-3957
        • Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical center
      • New York, New York, United States, 10016-2708
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
    • North Carolina
      • Durham, North Carolina, United States, 27710-2000
        • Duke Cancer Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920-1511
        • University of Tennessee Medical Center
    • Texas
      • Dallas, Texas, United States, 75390-7208
        • UT Southwestern Medical Center
      • San Antonio, Texas, United States, 78229-4427
        • UT Health San Antonio Mays Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031-2171
        • Virginia Cancer Specialists
    • Washington
      • Spokane Valley, Washington, United States, 99216-1020
        • Cancer Care Northwest
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System Institute for Research and Innovation

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must have measurable disease as defined per RECIST((Response Evaluation Criteria in Solid Tumors) version 1.1
  • Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition)
  • No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting except for the induction treatment of first-line therapy. Note: Local regional treatment performed during induction systemic treatment is allowed
  • Participants who have completed the first-line induction treatment, with an overall response of stable disease or better. The duration of induction treatment should be completed within approximately 6 months. The first dose of study treatment needs to occur within 2 weeks (for 2-week regimen) or 3 weeks (for 3-week regimen) to 6 weeks after Day 1 of the last cycle of induction therapy

Exclusion Criteria:

  • Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
  • Progressive disease occurred less than 6 months from completion of any prior neoadjuvant therapy (ie, chemotherapy with or without radiotherapy) or adjuvant therapy (ie, chemotherapy with or without radiotherapy), whichever occurred later
  • Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment
  • Any prior therapy targeting T-cell stimulation or checkpoint pathways
  • Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations
  • Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method

Note: Other protocol defined criteria may 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Other Names:
  • LBL-007
Drug: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Other Names:
  • BGB-A317
Drug: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Drug: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Drug: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Other Names:
  • LBL-007
Drug: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Other Names:
  • BGB-A317
Drug: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Drug: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine

Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.

The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Drug: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Other Names:
  • LBL-007
Drug: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Other Names:
  • BGB-A317
Drug: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Drug: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 2: Arm A:PD-L1-positive: Alcestobart High Dose +Tislelizumab + Bevacizumab +Fluoropyrimidine
PD-L1 (programmed cell death protein ligand-1)-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Drug: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Other Names:
  • LBL-007
Drug: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Other Names:
  • BGB-A317
Drug: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Drug: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Drug: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Other Names:
  • LBL-007
Drug: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Drug: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Active Comparator: Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine

PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.

The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Drug: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Drug: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Experimental: Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Drug: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
Other Names:
  • LBL-007
Drug: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Other Names:
  • BGB-A317
Drug: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Drug: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Active Comparator: Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine

PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.

The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Drug: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Drug: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame: From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (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/incapacity,
  • was a congenital anomaly/birth defect.
From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Time Frame: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occured first.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Time Frame: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

  • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)
Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Time Frame: From first documented response until disease progression or death (maximum follow-up time for DOR was 4.2 months)
DOR is defined as the time from the first determination of an objective confirmed response after randomization until the first documentation of disease progression or death, whichever comes first.
From first documented response until disease progression or death (maximum follow-up time for DOR was 4.2 months)
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E
Time Frame: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months)
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months)
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Negative Arms D and E
Time Frame: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months))

ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

  • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months))
Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Negative Arms D and E
Time Frame: From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)
DOR, defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first.
From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)
Phase 2: Number of Participants With Treatment-emergent AEs and SAEs
Time Frame: From first dose of study drug up to 30 days after last dose; maximum time on treatment in Phase 2 was 10.9 months

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (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/incapacity,
  • was a congenital anomaly/birth defect.
From first dose of study drug up to 30 days after last dose; maximum time on treatment in Phase 2 was 10.9 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)

January 29, 2023

Primary Completion (Actual)

May 23, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-A317-LBL-007-201
  • CTR20223077 (Registry 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

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.

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