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ACTIVE NOT RECRUITING
NCT05609370
PHASE1/PHASE2

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

Sponsor: BeiGene

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

113

Start Date

2023-01-29

Completion Date

2026-12-31

Last Updated

2025-10-02

Healthy Volunteers

No

Interventions

DRUG

LBL-007

Administered intravenously.

DRUG

Tislelizumab

Administered intravenously.

DRUG

Bevacizumab or Bevacizumab biosimilar

Administered intravenously

DRUG

Capecitabine

Administered in accordance with relevant local guidelines and/or prescribing information

DRUG

5-Fluorouracil

Administered in accordance with relevant local guidelines and/or prescribing information

Locations (76)

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