drugset
drugset / Trial / NCT05609370

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

NCT05609370 ↗

Phase 1/2 Active not recruiting 113 enrolled BeiGene
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-01-29
Primary completion
2025-05-23
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Alcestobart Monoclonal antibody 150 mg Intravenous
Subject Alcestobart Monoclonal antibody 200 mg Intravenous
Subject Alcestobart Monoclonal antibody 300 mg Intravenous
Subject Alcestobart Monoclonal antibody 400 mg Intravenous
Subject Alcestobart Monoclonal antibody 600 mg Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Subject Tislelizumab Monoclonal antibody 300 mg Intravenous
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Background Capecitabine Small molecule 850 mg/m2 Oral
Background Leucovorin Small molecule — Intravenous
Background Levoleucovorin Unknown — Intravenous
Background fluorouracil Small molecule 1600 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

colorectal cancer