drugset / Trial / NCT04673448

Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

NCT04673448

Phase 1 Active not recruiting 18 enrolled University of Washington GlaxoSmithKline · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase IB trial evaluates the effect of niraparib and TSR-042 in treating patients with BRCA-mutated breast, pancreas, ovary, fallopian tube, or primary peritoneal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as TSR-042, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and TSR-042 may kill more cancer cells.

Timeline

Start
2021-10-18
Primary completion
2025-12-31
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dostarlimab Monoclonal antibody Intravenous
Subject Niraparib Small molecule Oral