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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/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

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

NCT05609370•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must have measurable disease as defined per RECIST 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

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.

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

Key Dates

Start Date

January 29, 2023

Primary Completion Date

May 23, 2025

Completion Date

December 31, 2026

Last Updated

October 2, 2025

Enrollment

113

ACTUAL participants

Conditions

Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

Interventions

LBL-007

DRUG

Tislelizumab

DRUG

Bevacizumab or Bevacizumab biosimilar

DRUG

Capecitabine

DRUG

5-Fluorouracil

DRUG