This study is designed to establish the safety of the combination of PD-1 inhibitor tislelizumab, an anti-angiogenic agent bevacizumab and a chemotherapeutic agent capecitabine, in a phase Ib setting and to evaluate preliminary efficacy in selected expansion cohorts, including PD-L1-negative metastatic triple negative breast cancer (TNBC) and patients with active CNS disease. A sequential approach to cohort expansion will allow further evaluation in hormone receptor positive (HR+), HER2 negative (HER2-) disease if a signal of activity is observed in PD-L1 negative TNBC.
General Inclusion Criteria
Age 21 years or older at the time of informed consent.
Histologically or cytologically confirmed advanced or metastatic solid tumor.
Patients must have received at least one prior line of standard systemic therapy for locally advanced/unresectable or metastatic disease, OR be ineligible for, intolerant of, or have declined standard-of-care therapy, with the specific reason documented in the source records.
General Exclusion Criteria
Treatment with an investigational agent within 14 days prior to first dose of study treatment.
Known hypersensitivity or contraindication to tislelizumab, bevacizumab, capecitabine, fluoropyrimidines, or any excipients of the study drugs.
Known clinically significant dihydropyrimidine dehydrogenase deficiency.
Sequential
Tislelizumab + Bevacizumab + Capecitabine
DrugPhase Ib Dose Levels Dose Level DL1 (Starting Dose) * Tislelizumab: 200 mg IV Day 1 q3w * Bevacizumab: 7.5 mg/kg IV Day 1 q3w * Capecitabine: 1000 mg/m² PO BID Days 1-14 q3w DL-1 (De-escalation) * Tislelizumab: 200 mg IV Day 1 q3w * Bevacizumab: 7.5 mg/kg IV Day 1 q3w * Capecitabine: 800 mg/m² PO BID Days 1-14 q3w
Phase Ib: Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v5.0
Phase Ib: Phase II recommended dose of capecitabine in combination with tislelizumab and bevacizumab
Phase II TNBC Cohort: 12-month progression-free survival rate with tislelizumab, bevacizumab and capecitabine
Phase II CNS Cohort: Intracranial objective response rate with tislelizumab, bevacizumab and capecitabine
Phase Ib: Incidence and severity of adverse events (AEs), including serious adverse events (SAEs) and immune-related adverse events (irAEs)
Phase II (TNBC, HR+/HER2- MBC): Objective response rate (ORR)
Phase II (TNBC, HR+/HER2- MBC): Disease control rate (DCR)
Phase II (TNBC, HR+/HER2- MBC): Duration of response (DoR)
All Phases and Cohorts: Association between tumor genetic biomarkers and treatment response (ORR, DCR, PFS)
All Phases and Cohorts: Association between tumor immunohistochemistry biomarkers and treatment response (ORR, DCR, PFS)
All Phases and Cohorts: Association between plasma protein biomarkers and treatment response (ORR, DCR, PFS)
All Phases and Cohorts: Association between circulating tumor DNA (ctDNA) levels and treatment response (ORR, DCR, PFS)
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