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

Last updated: June 9, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

N/A

Treatment

LBL-007

Capecitabine

Bevacizumab or Bevacizumab biosimilar

Clinical Study ID

NCT05609370
BGB-A317-LBL-007-201
CTR20223077
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must have measurable disease as defined per RECIST version 1.1

  • Has a histologically confirmed colorectal adenocarcinoma with metastatic orunresectable 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 settingexcept for the induction treatment of first-line therapy. Note: Local regionaltreatment performed during induction systemic treatment is allowed

  • Participants who have completed the first-line induction treatment, with an overallresponse of stable disease or better. The duration of induction treatment should becompleted within approximately 6 months. The first dose of study treatment needs tooccur within 2 weeks (for 2-week regimen) or 3 weeks (for 3-week regimen) to 6 weeksafter Day 1 of the last cycle of induction therapy

Exclusion

Exclusion Criteria:

  • Participants whose disease has become resectable at the investigator's discretionduring or after induction treatment are not eligible

  • Progressive disease occurred less than 6 months from completion of any priorneoadjuvant therapy (ie, chemotherapy with or without radiotherapy) or adjuvanttherapy (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)V600Emutations

  • Have locally or centrally confirmed microsatellite instability-high (MSI-H) bypolymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method

Note: Other protocol defined criteria may apply.

Study Design

Total Participants: 113
Treatment Group(s): 7
Primary Treatment: LBL-007
Phase: 1/2
Study Start date:
January 29, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Border Medical Oncology

    East Albury, New South Wales 2640
    Australia

    Site Not Available

  • Cancer Care Foundation

    Miranda, New South Wales 2228
    Australia

    Site Not Available

  • Orange Health Service (Central West Cancer Care Centre)

    Orange, New South Wales 2800
    Australia

    Site Not Available

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales 2650
    Australia

    Site Not Available

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Site Not Available

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Site Not Available

  • Icon Cancer Care South Brisbane

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Icon Cancer Care- South Brisbane

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Flinders Centre For Innovation in Cancer (Fcic)

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia 5112
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • St John of God, Murdoch

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • One Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing 102218
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian 362000
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Gansu Provincial Hospital

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong 515041
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Nantong First Peoples Hospital

    Nantong, Jiangsu 215124
    China

    Site Not Available

  • Affiliated Hospital of Jiangnan University South Campus

    Wuxi, Jiangsu 214122
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • Baoji Central Hospital

    Baoji, Shaanxi 721008
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Jining No Peoples Hospital

    Jining, Shandong 272000
    China

    Active - Recruiting

  • Jining No Peoples Hospital West Branch

    Jining, Shandong 272000
    China

    Active - Recruiting

  • Jining No.1 People'S Hospital

    Jining, Shandong 272000
    China

    Active - Recruiting

  • Jining No.1 Peoples Hospital West Branch

    Jining, Shandong 272000
    China

    Site Not Available

  • Linyi Peoples Hospital

    Linyi, Shandong 276000
    China

    Site Not Available

  • Qingdao Municipal Hospital

    Qingdao, Shandong 266000
    China

    Site Not Available

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Shanghai 10Th Peoples Hospital

    Shanghai, Shanghai 200072
    China

    Site Not Available

  • Shanghai East Hospital Branch Hospital

    Shanghai, Shanghai 200123
    China

    Site Not Available

  • Shanghai Th Peoples Hospital

    Shanghai, Shanghai 200072
    China

    Active - Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030013
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Tianjin Union Medical Center (Nankai University Affiliated Hospital)

    Tianjin, Tianjin 300121
    China

    Site Not Available

  • Karamay Central Hospital of Xinjiang

    Karamay, Xinjiang 834009
    China

    Site Not Available

  • The Xinjiang Uygur Autonomous Region Peoples Hospital

    Urumqi, Xinjiang 830001
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Zhejiang University College of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • Zhejiang University College of Medicine- Second Affiliated Hospital

    Hangzhou, Zhejiang 310017
    China

    Active - Recruiting

  • Pan American Center for Oncology Trials

    Rio Piedras, 00935
    Puerto Rico

    Active - Recruiting

  • Pan American Oncology Trials, Llc

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Alaska Oncology

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Alaska Oncology and Hematology, Llc

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Alaska Oncologyand Hematology, Llc

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Banner Md Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Mayo Clinic Phoenix

    Phoenix, Arizona 85254
    United States

    Site Not Available

  • Toi Clinical Research

    Cerritos, California 90703
    United States

    Site Not Available

  • Kaiser Permanente Southern California

    Irvine, California 92618
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California 90033
    United States

    Site Not Available

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Site Not Available

  • Hoag Memorial Presbyterian

    Newport, California 92663
    United States

    Site Not Available

  • Scripps Health

    San Diego, California 92103
    United States

    Site Not Available

  • Toi Clinical Research

    Santa Ana, California 92705
    United States

    Site Not Available

  • Kaiser Permanente Northern California

    Vallejo, California 94510
    United States

    Site Not Available

  • Baptist Md Anderson Cancer Center

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Pontchartrain Cancer Center

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Ochsner Clinical Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Minnesota Oncology Hematology Pa

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • St Vincent Frontier Cancer Center

    Billings, Montana 59102
    United States

    Site Not Available

  • St. Vincent Frontier Cancer Center

    Billings, Montana 59102
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Cancer Care Specialists

    Reno, Nevada 89511
    United States

    Site Not Available

  • Md Anderson Cancer Center At Cooper

    Camden, New Jersey 08103
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • New York Oncology Hematology

    Albany, New York 12206
    United States

    Site Not Available

  • NYU Langone - Winthrop Hospital

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • NYU Langone

    New York, New York 10016
    United States

    Active - Recruiting

  • Nyu Perlmutter Cancer Center

    New York, New York 10016
    United States

    Active - Recruiting

  • Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Oncology Hematology Care Clinical Trials, Llc

    Cincinnati, Ohio 45245
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29245
    United States

    Site Not Available

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Ut Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Texas Oncology Pa Grapevine

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Ut Health San Antonio Mays Cancer Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Oncology

    Tyler, Texas 75702
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Oncology and Hematology Associates of Southwest Virginia, Inc

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Cancer Care Northwest

    Spokane Valley, Washington 99216
    United States

    Site Not Available

  • Multicare Health System Institute For Research and Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

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