ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-10-24

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06077877

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Principal Investigator

GSK Clinical Trials

STUDY_DIRECTOR

GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site

San Francisco, California, 94158

United States

GSK Investigational Site

St Louis, Missouri, 63110

United States

GSK Investigational Site

Dallas, Texas, 75230

United States

GSK Investigational Site

Houston, Texas, 77030

United States

GSK Investigational Site

San Antonio, Texas, 78229

United States

GSK Investigational Site

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-24

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-10-24

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

POLQi
Niraparib
GSK4524101

Additional Relevant MeSH Terms

Neoplasms