Study on LBL-007 and Tislelizumab with Bevacizumab and Fluoropyrimidine for Advanced Colorectal Cancer

Sponsor: BeiGene

Sponsor score: 40

ClinicalTrials ID:NCT05609370

This clinical trial is testing a new combination of drugs, including LBL-007 and Tislelizumab, with standard treatments bevacizumab and fluoropyrimidine, to see if they are safe and effective for patients with advanced colorectal cancer that cannot be surgically removed.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug combination, LBL-007 and Tislelizumab, when used with bevacizumab and fluoropyrimidine in patients with colorectal cancer that has spread or cannot be removed by surgery. This study is in Phase 1b/2, which means it is testing both the safety and how well the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Have colorectal cancer that has spread or cannot be removed by surgery, confirmed by lab tests.
  • Have not received any previous treatments for colorectal cancer that has spread, except for initial treatment.
  • Have completed initial treatment with stable disease or better results.
  • Have at least one tumor that can be measured by scans.

Exclusion Criteria

  • Cancer has become operable during or after initial treatment.
  • Initial treatment started less than 6 months after finishing any previous chemotherapy or radiation.
  • Have been treated with anti-EGFR antibody during initial treatment.
  • Have had previous treatments targeting T-cell pathways.
  • Have a specific BRAF gene mutation (BRAF V600E).
  • Have high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) confirmed by specific tests.

Locations

FACILITYZIPCITYSTATE
Alaska Oncologyand Hematology, Llc99508AnchorageAlaska
Banner Md Anderson Cancer Center85234GilbertArizona
Toi Clinical Research90703CerritosCalifornia
Usc Norris Comprehensive Cancer Center (Nccc)90033Los AngelesCalifornia
UCLA90095Los AngelesCalifornia
Hoag Memorial Presbyterian92663NewportCalifornia
Baptist Md Anderson Cancer Center32207JacksonvilleFlorida
Fort Wayne Medical Oncology and Hematology46804Fort WayneIndiana
Baptist Health Lexington40503LexingtonKentucky
University of Kentucky Markey Cancer Center40536LexingtonKentucky

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