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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06710847 | A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 14 | — | — | Dec 13, 2024 | Jun 22, 2026 | Feb 2, 2026 | 22 | United States, Australia +5 |
ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by investigator assessment.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose escalation of GSK4418959 monotherapy | EXPERIMENTAL | Participants will receive GSK4418959 as monotherapy. |
| Part 2: Dose expansion of GSK4418959 monotherapy | EXPERIMENTAL | Participants will receive GSK4418959 as monotherapy. |
| Part 3: Dose escalation of GSK4418959 plus PD-1 inhibitor | EXPERIMENTAL | Participants will receive GSK4418959 plus PD-1 inhibitor. |
| Name | Type | Description |
|---|---|---|
| GSK4418959 | DRUG | GSK4418959 will be administered. |
| PD-1 inhibitor | BIOLOGICAL | PD-1 inhibitor will be administered. |
Inclusion Criteria: Parts 1, 2, and 3 inclusion criteria: * Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor * Has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)...