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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 (Part 1).
* Participant has metastatic, gBRCAmut, HER2-negative or HER2-low breast cancer who has completed at most 3 or more prior lines of therapy (Part 2).
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.
Primary outcome measure(s)
Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period — Up to 28 days
Part 1 - Proportion of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period — Up to 28 days
Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period — Up to 28 days
Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period — Up to 28 days
Part 1 -Percentage of Participants who require dosage interruptions, dose reductions, and drug discontinuations due to adverse reactions during DLT Observation Period — Up to 28 days
Part 2 - Confirmed Objective Response Rate (ORR) — Up to approximately 52 weeks ORR is the percentage of participants with an Investigator-assessed confirmed complete response and confirmed partial response to treatment, as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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