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

Sponsor
GlaxoSmithKline
Study ID
NCT04544995
Phase
PHASE1
Status
Terminated

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
6 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 6, 2020
Status verified
Jan 2026
Primary completion
Apr 23, 2025
Completion
Apr 23, 2025

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: Dose Escalation
    Participants with body weight of ≥ 20 kilogram (kg) and who can swallow niraparib tablets will receive niraparib tablets and dostarlimab.
  • Experimental: Part 1B: Dose Escalation
    Participants who are \<8 years of age will receive niraparib TfOS and dostarlimab.
  • Experimental: Part 2 Safety Run-in
    Participants with osteosarcoma or neuroblastoma who are ≥8 years of age will receive niraparib TfOS and dostarlimab.
  • Experimental: Part 2A: Cohort Expansion for Osteosarcoma
    Participants with osteosarcoma will receive the RP2D of the combination of niraparib and dostarlimab.
  • Experimental: Part 2B: Cohort Expansion for Neuroblastoma
    Participants with neuroblastoma will receive the RP2D of the combination of niraparib and dostarlimab.

Primary Outcome Measure

Part 1A and Part 1B: Number of Participants With Dose-limiting Toxicities (DLT) [ Time Frame: Up to 42 days ]

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