A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of the oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP inhibitor (PARPi) niraparib in adult participants with solid tumors.

Condition studied

Neoplasms

Investigational medicinal product(s)

Eligibility

Primary endpoint

Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period, Part 1 - Proportion of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period, Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period, Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period, Part 1 - Percentage of Participants who require dosage interruptions, dose reductions, and drug discontinuations due to adverse reactions during DLT Observation Period, Part 2 - Confirmed Objective Response Rate (ORR)

Endpoint detail

Part 1 - Area Under Curve (AUC), Time to Maximum Concentration, and half-life of GSK4364973, Part 1 and 2 - Maximum Concentration (Cmax) of GSK4364973, Part 1 and 2 - Plasma Concentration of Niraparib, Part 1 - Number of Participants with TEAEs and SAEs based on Severity beyond DLT Observation Period, Part 1 - Duration of TEAEs and SAEs (Days) beyond DLT Observation Period, Part 2 - Number of Participants with TEAEs and SAEs based on Severity, Part 2 - Duration of Treatment Emergent AEs and SAEs (Days), Part 2 - Progression-free Survival (PFS), Part 2 - Duration of Response (DOR), Part 2 - Minimum Concentration (Cmin) of GSK4364973