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

Study acronym: TIBEC
StatusNot Yet Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Eligibility criteria expanded, about 39 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07681297
Lead Sponsor National University Hospital, Singapore
Conditions
(from sponsor)		 Advanced Solid Tumor Cancer, Triple-Negative Breast Cancer (TNBC), CNS Disease, Breast Cancer
Related terms Breast Neoplasms, Central Nervous System Diseases, Triple Negative Breast Neoplasms
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov