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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - GSK4524101 Monotherapy | Experimental |
| |
| Part 1 - GSK4524101 plus Niraparib | Experimental |
| |
| Part 1 - GSK4524101 Food Effect Cohort | Experimental |
| |
| Part 2 - GSK4524101 plus Niraparib | Experimental |
| |
| Part 2 - Niraparib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK4524101 | Drug | GSK452101 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period | Up to 28 days | |
| Part 1 - Proportion of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period | Up to 28 days | |
| Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period | Up to 28 days | |
| Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period | Up to 28 days | |
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 - Area Under Curve (AUC) of GSK4364973 (Metabolite of GSK4524101) | Up to 21 weeks | |
| Part 1 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101) | Up to 21 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Francisco | California | 94158 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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This is an open-label non-blinded study
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| Niraparib | Drug | Niraparib will be administered. |
|
| Part 1 - Time to Maximum Concentration of GSK4364973 (Metabolite of GSK4524101) |
| Up to 21 weeks |
| Part 1 - Half-life of GSK4364973 (Metabolite of GSK4524101) (Days) | Up to 21 weeks |
| Part 1 -Plasma Concentration of Niraparib | Up to 21 weeks |
| Part 1 - Number of Participants with TEAEs and SAEs based on Severity beyond DLT Observation Period | Up to approximately 24 weeks |
| Part 1 - Duration of TEAEs and SAEs (Days) beyond DLT Observation Period | Up to approximately 24 weeks |
| Part 2 - Number of Participants with TEAEs and SAEs based on Severity | Up to approximately 52 weeks |
| Part 2 - Duration of Treatment Emergent AEs and SAEs (Days) | Up to approximately 52 weeks |
| 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 |
| 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 |
| Part 2 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101) | Up to 21 weeks |
| Part 2 - Minimum Concentration (Cmin) of GSK4364973 (Metabolite of GSK4524101) | Up to 21 weeks |
| Part 2 -Plasma Concentration of Niraparib | Up to 21 weeks |
| 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 |
| GSK Investigational Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4A 3J1 | Canada |
| GSK Investigational Site | Panama City | Panama |
| GSK Investigational Site | Punta Pacifica Panama City Panama | Panama |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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