Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational University Hospital, Singapore

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tislelizumab + Bevacizumab + Capecitabine

Treatment groups

154 Participants
are divided into 4 treatment groups