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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

NCT ID: NCT06077877

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2026-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label non-blinded study

Study Groups

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Part 1 - GSK4524101 Monotherapy

Group Type EXPERIMENTAL

GSK4524101

Intervention Type DRUG

GSK452101 will be administered.

Part 1 - GSK4524101 plus Niraparib

Group Type EXPERIMENTAL

GSK4524101

Intervention Type DRUG

GSK452101 will be administered.

Niraparib

Intervention Type DRUG

Niraparib will be administered.

Part 1 - GSK4524101 Food Effect Cohort

Group Type EXPERIMENTAL

GSK4524101

Intervention Type DRUG

GSK452101 will be administered.

Part 2 - GSK4524101 plus Niraparib

Group Type EXPERIMENTAL

GSK4524101

Intervention Type DRUG

GSK452101 will be administered.

Niraparib

Intervention Type DRUG

Niraparib will be administered.

Part 2 - Niraparib

Group Type ACTIVE_COMPARATOR

Niraparib

Intervention Type DRUG

Niraparib will be administered.

Interventions

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GSK4524101

GSK452101 will be administered.

Intervention Type DRUG

Niraparib

Niraparib will be administered.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

St Louis, Missouri, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Fairfax, Virginia, United States

Site Status

GSK Investigational Site

Porto Alegre, , Brazil

Site Status

GSK Investigational Site

Vitória, , Brazil

Site Status

GSK Investigational Site

Edmonton, Alberta, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Panama City, , Panama

Site Status

GSK Investigational Site

Punta Pacifica Panama City Panama, , Panama

Site Status

Countries

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United States Brazil Canada Panama

Other Identifiers

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219590

Identifier Type: -

Identifier Source: org_study_id

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