Neoplasms Clinical Trial
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
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).
Status | Recruiting |
Enrollment | 135 |
Est. completion date | November 9, 2029 |
Est. primary completion date | December 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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. |
Country | Name | City | State |
---|---|---|---|
Canada | GSK Investigational Site | Edmonton | Alberta |
Canada | GSK Investigational Site | Ottawa | Ontario |
Canada | GSK Investigational Site | Toronto | Ontario |
United States | GSK Investigational Site | Dallas | Texas |
United States | GSK Investigational Site | Fairfax | Virginia |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | Saint Louis | Missouri |
United States | GSK Investigational Site | San Antonio | Texas |
United States | GSK Investigational Site | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1 - Number of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period | Up to 28 days | ||
Primary | Part 1 - Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period | Up to 28 days | ||
Primary | Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period | Up to 28 days | ||
Primary | Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period | Up to 28 days | ||
Primary | Part 1 -Percentage of Participants who require dosage interruptions, dose reductions, and drug discontinuations due to adverse reactions during DLT Observation Period | Up to 28 days | ||
Primary | Part 2 - Confirmed Objective Response Rate (ORR) | ORR is the percentage of participants with an Investigator-assessed confirmed complete response and confirmed partial response to treatment, as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 | Up to approximately 52 weeks | |
Secondary | Part 1 - Area Under Curve (AUC) of GSK4364973 (Metabolite of GSK4524101) | Up to 21 weeks | ||
Secondary | Part 1 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101) | Up to 21 weeks | ||
Secondary | Part 1 - Time to Maximum Concentration of GSK4364973 (Metabolite of GSK4524101) | Up to 21 weeks | ||
Secondary | Part 1 - Half-life of GSK4364973 (Metabolite of GSK4524101) (Days) | Up to 21 weeks | ||
Secondary | Part 1 -Plasma Concentration of Niraparib | Up to 21 weeks | ||
Secondary | Part 1 - Number of Participants with TEAEs and SAEs based on Severity beyond DLT Observation Period | Up to approximately 24 weeks | ||
Secondary | Part 1 - Duration of TEAEs and SAEs (Days) beyond DLT Observation Period | Up to approximately 24 weeks | ||
Secondary | Part 2 - Number of Participants with TEAEs and SAEs based on Severity | Up to approximately 52 weeks | ||
Secondary | Part 2 - Duration of Treatment Emergent AEs and SAEs (Days) | Up to approximately 52 weeks | ||
Secondary | Part 2 - Progression-free Survival (PFS) | PFS is time from randomization to progressive disease or death from any cause, whichever is earlier, as assessed via RECIST v1.1 by Investigator assessment | Up to approximately 52 weeks | |
Secondary | Part 2 - Duration of Response (DOR) | DOR is defined as time from first documented PR or better to disease progression (as assessed by RECIST v1.1 by investigator assessment) or death whichever is earlier for participants who have achieved a CR or PR | Up to approximately 52 weeks | |
Secondary | Part 2 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101) | Up to 21 weeks | ||
Secondary | Part 2 - Minimum Concentration (Cmin) of GSK4364973 (Metabolite of GSK4524101) | Up to 21 weeks | ||
Secondary | Part 2 -Plasma Concentration of Niraparib | Up to 21 weeks |
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