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Active (not recruiting) Phase 1/2 NCT06077877

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

Phase 1/2 – combined early trial
Conditions: Neoplasms

Sponsor: GlaxoSmithKline

trial.available_in: БГ
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).
Who can participate
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.
Interventions
GSK4524101
DRUG
Niraparib
DRUG
Locations 11
Canada (3)
GSK Investigational Site
Edmonton , Alberta
GSK Investigational Site
Montreal , Quebec
GSK Investigational Site
Toronto , Ontario
Panama (2)
GSK Investigational Site
Panama City
GSK Investigational Site
Punta Pacifica Panama City Panama
United States (6)
GSK Investigational Site
Dallas , Texas
GSK Investigational Site
Fairfax , Virginia
GSK Investigational Site
Houston , Texas
GSK Investigational Site
San Antonio , Texas
GSK Investigational Site
San Francisco , California
GSK Investigational Site
St Louis , Missouri
Technical details
Status
Active (not recruiting)
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.10.2023
Completion date
30.06.2026
Registry ID
NCT06077877
Source
clinicaltrials.gov
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