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Clinical trial No longer in our active list Phase1; Phase2 Interventional Ages 18 and up

Investigating GSK4524101 and Niraparib for treating solid tumors

Official title: 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

Run by GlaxoSmithKline · NCT06077877 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing a new cancer treatment called GSK4524101, both alone and with another drug called niraparib, to see how safe it is and how well it works for people with advanced solid tumors.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment135 (estimated)
SponsorGlaxoSmithKline
Industry-sponsored
Drugs / interventionschemotherapy
Locations10 sites (San Francisco, California and 9 other locations)
Trial IDNCT06077877 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors who have not responded to standard treatment options.

Probably not a fit

Patients with uncontrolled brain metastases or those currently participating in other treatment studies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety, tolerability, and pharmacokinetics of GSK4524101, both alone and in combination with niraparib, in patients with advanced solid tumors. It consists of two parts: a dose escalation phase to determine the maximum tolerated dose of GSK4524101 and a dose expansion phase to further assess its effects. Participants will be closely monitored for any adverse effects and the preliminary anticancer activity of the treatments will be evaluated.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have gone: Other studies have shown promising results with similar combinations of targeted therapies and chemotherapy agents, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* More than or equal to (≥)18 years of age
* Eastern cooperative oncology group (ECOG) class 0-2
* Life expectancy of a minimum of 3 month
* Participant has histologically diagnosed advanced or metastatic solid tumor and has exhausted all standard of care treatment options.

Exclusion Criteria:

* Participant has not recovered (i.e., to Grade less than or equal to \[≤1\] or to baseline) from prior chemotherapy-induced AEs.
* Participant is currently participating in a treatment study or has participated in a study of any investigational agent within 4 weeks of the first dose of treatment.
* Participant has symptomatic uncontrolled brain or leptomeningeal metastases.
* Participant has a known additional malignancy that progressed or required active treatment within the last 2 years
* Participant has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
* Participant has uncontrolled hypertension with sustained systolic blood pressure (BP) \>140 millimetres of mercury (mmHg) or diastolic BP \>90 mmHg.

Where it's running

  • GSK Investigational Site
    San Francisco, California, United States     Recruiting
  • GSK Investigational Site
    Miami, Florida, United States     Recruiting
  • GSK Investigational Site
    Saint Louis, Missouri, United States     Recruiting
  • GSK Investigational Site
    Dallas, Texas, United States     Recruiting
  • GSK Investigational Site
    Houston, Texas, United States     Recruiting
  • GSK Investigational Site
    San Antonio, Texas, United States     Recruiting
Show 4 more locations
  • GSK Investigational Site
    Fairfax, Virginia, United States     Recruiting
  • GSK Investigational Site
    Edmonton, Alberta, Canada     Recruiting
  • GSK Investigational Site
    Ottawa, Ontario, Canada     Recruiting
  • GSK Investigational Site
    Toronto, Ontario, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.