For Healthcare Professionals

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

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Participant must have measurable disease as defined per RECIST version 1.1
  2. Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition)
  3. 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
  4. 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

Exclusion Criteria:


  1. Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
  2. 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
  3. Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment
  4. Any prior therapy targeting T-cell stimulation or checkpoint pathways
  5. Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations
  6. 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.


pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

Age (in years)

18+

Phase

PHASE1/PHASE2

Participants needed

113

Est. Completion Date

Dec 31, 2026

Treatment type

INTERVENTIONAL


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT05609370

Study number

BGB-A317-LBL-007-201

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.