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 study on Neoplasms Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Pamela Munster
Headshot of Pamela Munster
Pamela Munster

Description

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).

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

Keywords

Neoplasms, POLQi, Niraparib, GSK4524101, GSK4524101 Monotherapy, GSK4524101 plus Niraparib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

  • GSK Investigational Site accepting new patients
    San Francisco California 94158 United States
  • GSK Investigational Site accepting new patients
    Edmonton Alberta T6G 1Z2 Canada

Lead Scientist at UCSF

  • Pamela Munster
    Professor, Medicine, School of Medicine. Authored (or co-authored) 161 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GlaxoSmithKline
ID
NCT06077877
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 135 study participants
Last Updated
Contact us about this trial