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
Inactive

ClinicalTrials ID:NCT05609370

Patient View

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.

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