A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
Description
Brief 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 fluoropyrimidine to
participants with colorectal cancer.
Phase
N/AInclusion and Exclusion 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
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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