A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Capecitabine Versus Bevacizumab Plus Capecitabine in Participants With Unresectable or Metastatic Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

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 capecitabine to participants with colorectal cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Bevacizumab; Capecitabine

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

• 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 documented B-raf proto-oncogene, serine/threonine kinase (BRAF) mutations by local assessments

• Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or deficient mismatch repair (dMMR) immunohistochemistry (IHC). Local result is recommended and acceptable for enrollment. Participants without local testing results are required to have a central laboratory assessment. Note: CRC patients with tumors without mismatch repair (MMR) deficiency or MSI-H status are categorized as pMMR or microsatellite stable (MSS)

Note: Other protocol defined criteria may apply.