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GS-5319 · 1 trial · 1 indication
| 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 based on the selected indications to receive GS-5319 monotherapy at the recommended dose during the monotherapy dose expansion phase. |
| Part C: GS-5319 Monotherapy Dose Optimization | EXPERIMENTAL | Participants will be randomized based on the selected indications to receive GS-5319 monotherapy at one of the recommended doses during the monotherapy dose optimization phase. |
| Part D: GS-5319 Combination Therapy Dose Escalation | EXPERIMENTAL | Participants will receive escalating doses of GS-5319 as combination therapy with carboplatin, pemetrexed, pembrolizumab, 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 escalation phase. |
| Name | Type | Description |
|---|---|---|
| GS-5319 | DRUG | Administered orally |
| Carboplatin | DRUG | Administered intravenously |
| Pemetrexed | DRUG | Administered intravenously |
| Pembrolizumab | DRUG | Administered intravenously |
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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
GS-5319 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently being studied in a Phase 1 clinical trial in adults with advanced solid tumors, both as a single agent and in combination with other therapies.
GS-5319 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of GS-5319 in patients with advanced solid tumors.
GS-5319 is in Phase 1 of clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in advanced solid tumors.
GS-5319 is being evaluated in a Phase 1 clinical trial with the identifier NCT07128303. The trial is titled 'Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors' and is currently recruiting participants in the United States, South Korea, and Spain. The study plans to enroll 476 adults aged 18 years and older.
GS-5319 is being studied both alone and in combination with other therapies. The ongoing Phase 1 trial, NCT07128303, is designed to evaluate GS-5319 as a single agent and in combination regimens for the treatment of advanced solid tumors in adults.