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NCT06077877Recruiting

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

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
GlaxoSmithKlinePhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Neoplasms
Drug/Device/Intervention
GSK4524101
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Location
San Francisco,Saint Louis,Dallas,Houston,San Antonio,Fairfax,Toronto, Canada,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Oct 24, 2023
End date
Nov 04, 2025
Enrollment
112 participants
Primary outcome

Part 1 - Number of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period,Part 1 - Number 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)

Summary

The primary purpose of this study is to determine the maximum tolerated dose of GSK4524101
 monotherapy (MTD) and GSK4524101 in combination with niraparib (MTDc). The study consists of
 two parts - Part 1 (Dose Escalation) and Part 2 (Dose Expansion).

ICD-10 classifications
NeoplasmsIn situ neoplasmsPersonal history of other neoplasmsBenign neoplasmsMalignant neoplasms
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06077877
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06077877 through Pure Global AI's free database. This Phase 1 trial is sponsored by GlaxoSmithKline and is currently Recruiting. The study focuses on Neoplasms. Target enrollment is 112 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.