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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeiGene

About this trial

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).

Eligibility criteria

Qualifiers

Having histological confirmed diagnosis of malignancy

Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR

Having received prior cancer therapy regimen(s) for advanced disease.

At least 1 measurable lesion as defined per RECIST Version (v) 1.1

Disqualifiers

Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Active leptomeningeal disease or uncontrolled brain metastasis.

Clinically significant pleural effusion, pericardial effusion or ascites

Active autoimmune diseases or history of autoimmune diseases that may relapse

Trial design

Treatments tested in this trial

  • Tislelizumab (BGB-A317)

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators