A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors - Trial NCT06077877
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.
Study Focus
Sponsor & Location
GlaxoSmithKline
Timeline & Enrollment
Phase 1
Oct 24, 2023
Nov 04, 2025
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
Data Source
ClinicalTrials.gov
NCT06077877
Non-Device Trial