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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

NCT05609370 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2025-10-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-29
Primary Completion
2025-05-23
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609370 on ClinicalTrials.gov