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

Sponsor: GlaxoSmithKline

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06077877

Patient View

This clinical trial evaluates the safety and efficacy of GSK4524101, alone or with niraparib, in adults with advanced solid tumors who have no remaining standard treatment options. Participants must be 18 or older, with an ECOG status of 0-2 and a life expectancy of at least 3 months. The study includes dose escalation and expansion phases to determine optimal dosing.

Patient Parameters

Program Overview

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).

Eligibility 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.

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