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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 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Niraparib
- DRUG GSK4524101
Study Locations (13)
Other
- GSK Investigational Site — Porto Alegre
- GSK Investigational Site — Vitória
- GSK Investigational Site — Panama City
- GSK Investigational Site — Punta Pacifica Panama City Panama
Texas
- GSK Investigational Site — Dallas
- GSK Investigational Site — Houston
- GSK Investigational Site — San Antonio
California
- GSK Investigational Site — San Francisco
Missouri
- GSK Investigational Site — St Louis
Virginia
- GSK Investigational Site — Fairfax
Alberta
- GSK Investigational Site — Edmonton
Ontario
- GSK Investigational Site — Toronto
Quebec
- GSK Investigational Site — Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2023-10-24 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06077877
The ClinicalTrials.gov registry entry for NCT06077877 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 2 interventions — of which Niraparib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06077877 reports 13 study locations spanning 8 distinct geographic areas — top geographies include Other, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06077877 about?
NCT06077877 is a clinical study titled "A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors". 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).
What is the current status of trial NCT06077877?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2023-10-24. Estimated completion is 2026-06-30.
What conditions does trial NCT06077877 study?
This clinical trial studies the following conditions: Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06077877?
The interventions under investigation include: Niraparib (DRUG), GSK4524101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06077877?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06077877 being conducted?
This trial has 13 study locations across California, Missouri, Texas, Virginia, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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