A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Capecitabine Versus Bevacizumab Plus Capecitabine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
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.
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Participant must have measurable disease as defined per RECIST version 1.1
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Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition)
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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
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Participants who have completed the first-line induction treatment, with an overall response of stable disease or better
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Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
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Induction treatment initiated less than 6 months from completion of any prior neoadjuvant or adjuvant chemotherapy or radiotherapy which occurred later
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Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment
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Any prior therapy targeting T-cell stimulation or checkpoint pathways
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Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations
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Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method
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