drugset / Trial / NCT04544995
Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)
Non-randomizedSequentialOpen-labelTreatment
Summary
This study will evaluate the combination of a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, niraparib, with the programmed cell death protein 1 (PD-1) inhibitor, dostarlimab in the paediatric population. This study will be conducted to determine the recommended Phase 2 dose (RP2D) and evaluate the pharmacokinetics (PK), safety, and efficacy of niraparib in combination with dostarlimab in paediatric participants with recurrent or refractory solid tumors.
Timeline
- Start
- 2020-10-06
- Primary completion
- 2025-04-23
- Completion
- 2025-04-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dostarlimab | Monoclonal antibody | — | Intravenous |
| Subject | Niraparib | Small molecule | — | Oral |