NCT05609370

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-29
• Primary completion: 2025-05-23
• Completion: 2026-12-31
• First posted: 2022-11-08
• Last updated: 2025-10-02

Locations

76 sites across 4 countries: United States, Australia, China, Puerto Rico

Regulatory

• FDA-regulated drug study