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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP Inhibitor (PARPi) Niraparib in Adult Participants With Solid Tumors

NCT06077877•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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

Age

18 - No limit years

Sex

ALL

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.

Locations (13)

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Fairfax, Virginia, United States

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Vitória, Brazil

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Toronto, Ontario, Canada

Key Dates

Start Date

October 24, 2023

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2026

Last Updated

February 2, 2026

Enrollment

ACTUAL participants

Conditions

Neoplasms

Interventions

GSK4524101

DRUG

Niraparib

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

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