Trials / Active Not Recruiting
Active Not RecruitingNCT06077877
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With 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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK4524101 | GSK452101 will be administered. |
| DRUG | Niraparib | Niraparib will be administered. |
Timeline
- Start date
- 2023-10-24
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2023-10-11
- Last updated
- 2026-02-02
Locations
13 sites across 4 countries: United States, Brazil, Canada, Panama
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06077877. Inclusion in this directory is not an endorsement.