NCT04544995

Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)

A Phase 1, Multicentre, Open-Label, Dose-Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Patients With Recurrent or Refractory Solid Tumours

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Niraparib (Tablet for oral suspension)	Niraparib will be administered as TfOS (Tablet for oral suspension)
DRUG	Dostarlimab	Dostarlimab will be administered as IV infusion
DRUG	Niraparib (Tablet)	Niraparib will be administered as tablet

Timeline

• Start date: 2020-10-06
• Primary completion: 2025-04-23
• Completion: 2025-04-23
• First posted: 2020-09-10
• Last updated: 2026-01-21
• Results posted: 2026-01-21

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study