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

Part of paid clinical trials in San Francisco, California.

Sponsor
GlaxoSmithKline
Study ID
NCT06077877
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GSK4524101 — DRUG
    GSK452101 will be administered.
  • Niraparib — DRUG
    Niraparib will be administered.

Study Details

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).

Key Dates

Start date
Oct 24, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - GSK4524101 Monotherapy
  • Experimental: Part 1 - GSK4524101 plus Niraparib
  • Experimental: Part 1 - GSK4524101 Food Effect Cohort
  • Experimental: Part 2 - GSK4524101 plus Niraparib
  • Active Comparator: Part 2 - Niraparib

Primary Outcome Measure

Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period [ Time Frame: Up to 28 days ]

Locations (6)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteSan FranciscoCalifornia94158-
GSK Investigational SiteSt LouisMissouri63110-
GSK Investigational SiteDallasTexas75230-
GSK Investigational SiteHoustonTexas77030-
GSK Investigational SiteSan AntonioTexas78229-
GSK Investigational SiteFairfaxVirginia22031-

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GSK Investigational Site· San Francisco, CAGSK Investigational Site· St Louis, MOGSK Investigational Site· Dallas, TXGSK Investigational Site· Houston, TXGSK Investigational Site· San Antonio, TXGSK Investigational Site· Fairfax, VA

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