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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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
GS-5319 is an investigational small molecule being developed by Gilead Sciences, Inc. for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is designed as a biomarker-selected therapy, meaning patients are enrolled based on specific biomarker criteria rather than an unselected tumor population.
GS-5319 is being studied for the treatment of advanced solid tumors in adults. It is an investigational agent and has not been approved for any indication. The Phase 1 trial enrolls patients with advanced solid tumors and evaluates GS-5319 given alone or in combination with other agents.
GS-5319 is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating the compound in advanced solid tumors.
GS-5319 is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The single ongoing Phase 1 study is currently recruiting participants and is designed to evaluate GS-5319 given alone or in combination in adults with solid tumors.
GS-5319 is being evaluated in one Phase 1 trial, NCT07128303, titled Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors. The trial is recruiting, has an enrollment of 476 participants, and is conducted in the United States, South Korea, and Spain.
The Phase 1 trial NCT07128303 enrolls adults 18 years of age and older of any sex with advanced solid tumors. Healthy volunteers are not eligible. The study is biomarker selected, so participants must meet specific biomarker criteria, and it uses a controlled design without randomization or double blinding.