๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-23

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors (NCT06077877)

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

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: GlaxoSmithKline

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: GSK Investigational Site โ€” San Francisco, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

  • GSK Investigational Site โ€” San Francisco, California
  • GSK Investigational Site โ€” St Louis, Missouri
  • GSK Investigational Site โ€” Dallas, Texas
  • GSK Investigational Site โ€” Houston, Texas
  • GSK Investigational Site โ€” San Antonio, Texas
  • GSK Investigational Site โ€” Fairfax, Virginia
  • GSK Investigational Site โ€” Edmonton, Alberta
  • GSK Investigational Site โ€” Toronto, Ontario
  • GSK Investigational Site โ€” Montreal, Quebec
  • GSK Investigational Site โ€” Panama City,
  • GSK Investigational Site โ€” Punta Pacifica Panama City Panama,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Neoplasms clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—