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

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).

Conditions

Neoplasms

Talk to us

Study Overview

On this page

Study Details

Study 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).

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

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

Condition
Neoplasms
Intervention / Treatment

-

Contacts and Locations

San Francisco

GSK Investigational Site, San Francisco, California, United States, 94158

Miami

GSK Investigational Site, Miami, Florida, United States, 33136

Saint Louis

GSK Investigational Site, Saint Louis, Missouri, United States, 63110

Dallas

GSK Investigational Site, Dallas, Texas, United States, 75230

Houston

GSK Investigational Site, Houston, Texas, United States, 77030

San Antonio

GSK Investigational Site, San Antonio, Texas, United States, 78229

Fairfax

GSK Investigational Site, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GlaxoSmithKline,

GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

2029-11-09