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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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.
National University Hospital, Singapore
Lead sponsor