A Phase 1, Multicentre, Open-label, Dose-Escalation and Cohort Expansion Study of Niraparib und Dostarlimab in Paediatric Patients with Recurrent or Refractory Solid Tumors (SCOOP)
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 pediatric 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 pediatric participants with recurrent or refractory solid tumors (excluding brain tumors).
Niraparib inhibits the function of the enzyme PARP (poly [adenosine diphosphate ribose] polymerase) in the body. As part of the study (part 1), tumors are therefore treated whose genetic information carries a specific signature called “BRCAness”.
Dostarlimab is a monoclonal antibody from the group of checkpoint inhibitors and is intended to strengthen the body's immune response to the tumor tissue and thus contribute to reduced tumor growth.
Niraparib is taken daily in the form of tablets or liquid suspension, dostarlimab is given as an infusion, always on the 1st day of a 21-day treatment cycle.
GlaxoSmithKline