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

Sponsor: BeiGene

Sponsor score: 40

ClinicalTrials ID:NCT05609370

This Phase 1b/2 study evaluates the efficacy and safety of LBL-007 and Tislelizumab with bevacizumab and fluoropyrimidine in colorectal cancer. Eligible participants have measurable, metastatic, or unresectable colorectal adenocarcinoma and have completed first-line induction treatment. Interventions include varying doses of LBL-007, Tislelizumab, bevacizumab, capecitabine, and 5-fluorouracil.

Patient Parameters

Program Overview

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 to participants with colorectal cancer.

Eligibility Criteria

Inclusion Criteria

  • Participant must have measurable disease as defined per RECIST version 1.1
  • Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition)
  • 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
  • Participants who have completed the first-line induction treatment, with an overall response of stable disease or better

Exclusion Criteria

  • Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
  • Induction treatment initiated less than 6 months from completion of any prior neoadjuvant or adjuvant chemotherapy or radiotherapy which occurred later
  • Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment
  • Any prior therapy targeting T-cell stimulation or checkpoint pathways
  • Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations
  • 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.

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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