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

Phase 2Active Not RecruitingNCT06077877

GlaxoSmithKline42 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

GSK4524101DRUG

GSK452101 will be administered.

NiraparibDRUG

Niraparib will be administered.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Dallas, Texas, United States

Outcomes

Primary Outcomes

Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period

Time frame: 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

Time frame: Up to 28 days

Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period

Time frame: Up to 28 days

Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period

Time frame: 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

Time frame: Up to 28 days

Part 2 - Confirmed Objective Response Rate (ORR)

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

Time frame: Up to approximately 52 weeks

Secondary Outcomes

Part 1 - Area Under Curve (AUC) of GSK4364973 (Metabolite of GSK4524101)

Time frame: Up to 21 weeks

Part 1 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101)

Time frame: Up to 21 weeks

Part 1 - Time to Maximum Concentration of GSK4364973 (Metabolite of GSK4524101)

Data from ClinicalTrials.gov

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