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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07128303 | Study of GS-5319 in Adults With Solid Tumors | PHASE1 | RECRUITING | 178 | — | — | Aug 28, 2025 | May 1, 2028 | May 26, 2026 | 9 | United States, South Korea +1 |
| Arm | Type | Description |
|---|---|---|
| Part A: GS-5319 Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive escalating doses of GS-5319 monotherapy, until disease progression, or until the participants meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first to determine the recommended dose for dose expansion phase. |
| Part B: GS-5319 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will be enrolled in different cohorts based on the selected indications to receive GS-5319 monotherapy at the recommended dose during the monotherapy dose expansion phase. |
| Name | Type | Description |
|---|---|---|
| GS-5319 | DRUG | Administered orally |
Key Inclusion Criteria: * Participants diagnosed with histologically or cytologically confirmed solid tumor types who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy in the advanced setting (locally-advanced or metastatic). * Part...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |