Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE1 | ACTIVE NOT_RECRUITING | 42 | — | — | Oct 24, 2023 | Jun 30, 2026 | Apr 24, 2026 | 11 | United States, Canada +1 |
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
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| GSK4524101 | DRUG | GSK452101 will be administered. |
| Niraparib | DRUG | Niraparib will be administered. |
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...