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

GlaxoSmithKline (GSK)

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Neoplasms

Treatments: Drug: GSK4524101; Drug: Niraparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06077877

219590

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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42 participants in 5 patient groups

Part 1 - GSK4524101 Monotherapy

Experimental group

Treatment:

Drug: GSK4524101

Part 1 - GSK4524101 plus Niraparib

Experimental group

Treatment:

Drug: Niraparib

Drug: GSK4524101

Part 1 - GSK4524101 Food Effect Cohort

Experimental group

Treatment:

Drug: GSK4524101

Part 2 - GSK4524101 plus Niraparib

Experimental group

Treatment:

Drug: Niraparib

Drug: GSK4524101

Part 2 - Niraparib

Active Comparator group

Treatment:

Drug: Niraparib