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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT05609370

Run by

BeiGene

People needed

113

Starts

2023-01-29

Expected to finish

2026-12-31

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Alaska Oncology and Hematology, Llc — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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