NCT03736889

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

A Single-Arm, Multi-Center, Open-Label, Phase 2 Study to Evaluate Efficacy and Safety of Tislelizumab (BGB-A317), an Anti-PD-1 Monoclonal Antibody, as Monotherapy in Patients With Previously-Treated Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) will be treated with anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317).

Conditions

• MSI-H/dMMR Solid Tumors

Interventions

Type	Name	Description
DRUG	Tislelizumab (BGB-A317)	Anti-PD-1 Antibody

Timeline

• Start date: 2018-09-19
• Primary completion: 2026-11-01
• Completion: 2027-09-01
• First posted: 2018-11-09
• Last updated: 2026-04-15

Locations

29 sites across 1 country: China