Phase 2 Study of Tislelizumab Anti-PD-1 Antibody Alone for Previously Treated Advanced or Metastatic MSI-H or dMMR Solid Tumors

What this Trial Is About

Researchers are evaluating the use of Tislelizumab BGB-A317, an anti-PD-1 monoclonal antibody, in adults with previously treated locally advanced unresectable or metastatic solid tumors that are mismatch repair deficient dMMR or microsatellite instability-high MSI-H. This Phase 2, single-arm, multi-center, open-label study aims to assess the efficacy and safety of Tislelizumab as monotherapy in this patient population. Participants will receive Tislelizumab as the study treatment. The study does not include a comparison group and involves ongoing treatment with Tislelizumab under medical supervision. The treatment period and assessment extend up to two years to evaluate response and survival outcomes. Throughout the study, participants will undergo regular evaluations including imaging and clinical assessments to measure tumor response using RECIST version 1.1 criteria. Researchers will monitor progression-free survival, overall survival, disease control rate, duration and time to response, as well as safety and tolerability through adverse event tracking. Participation may last up to two years, with ongoing safety monitoring during this time.

Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors