A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
NCT ID: NCT05609370
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
113 participants
INTERVENTIONAL
2023-01-29
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1b: Cohort -1: LBL-007 + Tislelizumab + Bevacizumab + Capecitabine
LBL-007 (low dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine
LBL-007
Administered intravenously.
Tislelizumab
Administered intravenously.
Bevacizumab or Bevacizumab biosimilar
Administered intravenously
Capecitabine
Administered in accordance with relevant local guidelines and/or prescribing information
Phase 1b: Cohort 1a: LBL-007 + Tislelizumab + Bevacizumab + Capecitabine
LBL-007 (medium dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine
LBL-007
Administered intravenously.
Tislelizumab
Administered intravenously.
Bevacizumab or Bevacizumab biosimilar
Administered intravenously
Capecitabine
Administered in accordance with relevant local guidelines and/or prescribing information
Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5-Fluorouracil (5-FU)
LBL-007 (medium dose) + tislelizumab (high dose once every 4 weeks) + bevacizumab (5 mg/kg once every 2 weeks) + 5-FU
LBL-007
Administered intravenously.
Tislelizumab
Administered intravenously.
Bevacizumab or Bevacizumab biosimilar
Administered intravenously
5-Fluorouracil
Administered in accordance with relevant local guidelines and/or prescribing information
Phase 1b: Cohort 2: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine
LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)
LBL-007
Administered intravenously.
Tislelizumab
Administered intravenously.
Bevacizumab or Bevacizumab biosimilar
Administered intravenously
Capecitabine
Administered in accordance with relevant local guidelines and/or prescribing information
5-Fluorouracil
Administered in accordance with relevant local guidelines and/or prescribing information
Phase 2: Arm A and Arm D: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine
LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)
LBL-007
Administered intravenously.
Tislelizumab
Administered intravenously.
Bevacizumab or Bevacizumab biosimilar
Administered intravenously
Capecitabine
Administered in accordance with relevant local guidelines and/or prescribing information
5-Fluorouracil
Administered in accordance with relevant local guidelines and/or prescribing information
Phase 2: Arm B: LBL-007 + Bevacizumab + Fluoropyrimidine
LBL-007 (high dose) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)
LBL-007
Administered intravenously.
Bevacizumab or Bevacizumab biosimilar
Administered intravenously
Capecitabine
Administered in accordance with relevant local guidelines and/or prescribing information
5-Fluorouracil
Administered in accordance with relevant local guidelines and/or prescribing information
Phase 2: Arm C and Arm E: Bevacizumab + Fluoropyrimidine
Bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)
LBL-007
Administered intravenously.
Tislelizumab
Administered intravenously.
Bevacizumab or Bevacizumab biosimilar
Administered intravenously
Capecitabine
Administered in accordance with relevant local guidelines and/or prescribing information
5-Fluorouracil
Administered in accordance with relevant local guidelines and/or prescribing information
Interventions
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LBL-007
Administered intravenously.
Tislelizumab
Administered intravenously.
Bevacizumab or Bevacizumab biosimilar
Administered intravenously
Capecitabine
Administered in accordance with relevant local guidelines and/or prescribing information
5-Fluorouracil
Administered in accordance with relevant local guidelines and/or prescribing information
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Alaska Oncology and Hematology, Llc
Anchorage, Alaska, United States
Banner Md Anderson Cancer Center
Gilbert, Arizona, United States
Toi Clinical Research
Cerritos, California, United States
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Hoag Memorial Presbyterian
Newport, California, United States
Kaiser Permanente Northern California
Vallejo, California, United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Pontchartrain Cancer Center
Covington, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Washington University School of Medicine
St Louis, Missouri, United States
St Vincent Frontier Cancer Center
Billings, Montana, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Cancer Care Specialists
Reno, Nevada, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
Ut Health San Antonio Mays Cancer Center
San Antonio, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Cancer Care Northwest
Spokane Valley, Washington, United States
Multicare Health System Institute For Research and Innovation
Tacoma, Washington, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Orange Health Service (Central West Cancer Care Centre)
Orange, New South Wales, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Flinders Centre For Innovation in Cancer (Fcic)
Bedford Park, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
St John of God, Murdoch
Murdoch, Western Australia, Australia
One Clinical Research
Nedlands, Western Australia, Australia
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Nanyang Central Hospital
Nanyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China
Nantong First Peoples Hospital
Nantong, Jiangsu, China
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Cancer Hospital
Jinan, Shandong, China
Jining No.1 Peoples Hospital West Branch
Jining, Shandong, China
Linyi Peoples Hospital
Linyi, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai 10Th Peoples Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Tianjin Union Medical Center (Nankai University Affiliated Hospital)
Tianjin, Tianjin Municipality, China
Karamay Central Hospital of Xinjiang
Karamay, Xinjiang, China
The Xinjiang Uygur Autonomous Region Peoples Hospital
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Pan American Oncology Trials, Llc
Rio Piedras, , Puerto Rico
Countries
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Other Identifiers
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CTR20223077
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-A317-LBL-007-201
Identifier Type: -
Identifier Source: org_study_id
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