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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
Sponsor: BeiGene
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.
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
2026-06-30
Healthy Volunteers
No
Conditions
Interventions
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
Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
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.
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.
Locations (64)
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, United States
Banner Md Anderson Cancer Center
Gilbert, Arizona, United States
Helios Clinical Research
Cerritos, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States
UCLA Hematologyoncology
Los Angeles, California, United States
Hoag Memorial Presbyterian
Newport Beach, 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 Comprehensive 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
Monash Health
Clayton, 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
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nantong First Peoples Hospital
Nantong, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shandong Cancer Hospital
Jinan, Shandong, China
Jining No1 Peoples Hospital West Branch
Jining, Shandong, China
Linyi Peoples Hospital
Linyi, Shandong, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
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