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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.

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520197-36-00
Acronym
219590
Enrollment
31
Registered
2025-11-03
Start date
Unknown
Completion date
2025-12-09
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Brief summary

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)

Detailed description

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

Interventions

Sponsors

Glaxosmithkline Research & Development Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
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

Countries

Belgium, Czechia, Denmark, Estonia, Greece, Italy, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026