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
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
2 other identifiers
interventional
113
4 countries
64
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2023
Longer than P75 for phase_1
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2022
CompletedFirst Posted
Study publicly available on registry
November 8, 2022
CompletedStudy Start
First participant enrolled
January 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2025
CompletedResults Posted
Study results publicly available
June 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedJuly 23, 2026
July 1, 2026
2.3 years
October 20, 2022
May 15, 2026
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
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
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 Outcomes (6)
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
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
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
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
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
From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)
- +1 more secondary outcomes
Study Arms (8)
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
EXPERIMENTALParticipants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
EXPERIMENTALParticipants 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).
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
EXPERIMENTALParticipants 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).
Phase 2: Arm A:PD-L1-positive: Alcestobart High Dose +Tislelizumab + Bevacizumab +Fluoropyrimidine
EXPERIMENTALPD-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).
Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
EXPERIMENTALPD-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).
Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine
ACTIVE COMPARATORPD-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).
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
EXPERIMENTALPD-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).
Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine
ACTIVE COMPARATORPD-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).
Interventions
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
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.
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (64)
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, 99508-2974, United States
Banner Md Anderson Cancer Center
Gilbert, Arizona, 85234-2165, United States
Helios Clinical Research
Cerritos, California, 90703, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067-2011, United States
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, 90089-1019, United States
UCLA Hematologyoncology
Los Angeles, California, 90095-3075, United States
Hoag Memorial Presbyterian
Newport Beach, California, 92663-4162, United States
Kaiser Permanente Northern California
Vallejo, California, 94589-2441, United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, 32207-8432, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Baptist Health Lexington
Lexington, Kentucky, 40503-1466, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536-7001, United States
Norton Cancer Institute
Louisville, Kentucky, 40217-1395, United States
Pontchartrain Cancer Center
Covington, Louisiana, 70433-7512, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2429, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
St Vincent Frontier Cancer Center
Billings, Montana, 59102-6746, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321, United States
Cancer Care Specialists
Reno, Nevada, 89511-2250, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102-4517, United States
Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital
Mineola, New York, 11501-3957, United States
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health
New York, New York, 10016-2708, United States
Columbia University Medical Center
New York, New York, 10032, United States
Duke Cancer Center
Durham, North Carolina, 27710-2000, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920-1511, United States
Ut Southwestern Medical Center
Dallas, Texas, 75390-7208, United States
Ut Health San Antonio Mays Cancer Center
San Antonio, Texas, 78229-4427, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031-2171, United States
Cancer Care Northwest
Spokane Valley, Washington, 99216-1020, United States
Multicare Health System Institute For Research and Innovation
Tacoma, Washington, 98405, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, Australia
Orange Health Service (Central West Cancer Care Centre)
Orange, New South Wales, NSW 2800, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, NSW 2650, Australia
Calvary Mater Newcastle
Waratah, New South Wales, NSW 2298, Australia
Pindara Private Hospital
Benowa, Queensland, QLD 4217, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
St John of God, Murdoch
Murdoch, Western Australia, WA 6150, Australia
One Clinical Research
Nedlands, Western Australia, WA 6009, Australia
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nantong First Peoples Hospital
Nantong, Jiangsu, 215124, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000, China
Linyi Peoples Hospital
Linyi, Shandong, 276000, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, 200123, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Union Medical Center (Nankai University Affiliated Hospital)
Tianjin, Tianjin Municipality, 300121, China
Karamay Central Hospital of Xinjiang
Karamay, Xinjiang, 834009, China
The Xinjiang Uygur Autonomous Region Peoples Hospital
Ürümqi, Xinjiang, 830001, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Pan American Oncology Trials, Llc
Rio Piedras, 00935, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2022
First Posted
November 8, 2022
Study Start
January 29, 2023
Primary Completion
May 23, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
July 23, 2026
Results First Posted
June 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See 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.