Investigating GSK4524101 and Niraparib for treating 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
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
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (San Francisco, California and 9 other locations) |
| Trial ID | NCT06077877 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors who have not responded to standard treatment options.
Not a fit: Patients with uncontrolled brain metastases or those currently participating in other treatment studies may not benefit from this study.
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 performed: Other studies have shown promising results with similar combinations of targeted therapies and chemotherapy agents, suggesting potential for success.
Eligibility criteria
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 this trial is running
San Francisco, California and 9 other locations
- 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)
- 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
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.