Gilead Sciences ((GILD)) announced an update on their ongoing clinical study.
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Gilead Sciences is initiating a Phase 1 clinical study titled ‘A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 in Adults With MTAP-deleted Advanced Solid Tumors.’ The study aims to assess the safety, tolerability, and optimal dosing of GS-5319, a drug targeting advanced solid tumors with a specific gene alteration. This gene alteration affects the production of the MTAP enzyme, which is crucial for normal cell growth.
The intervention being tested is GS-5319, an experimental drug administered orally. The study will explore its effects in two parts: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to further evaluate its efficacy at the recommended dose.
The study is designed as an interventional trial with a non-randomized, sequential model and no masking, focusing primarily on treatment. Participants will receive escalating doses of GS-5319 until disease progression or other discontinuation criteria are met.
Key dates for the study include its submission on August 13, 2025, with recruitment yet to begin. These dates are crucial for tracking the study’s progress and potential market entry of GS-5319.
The initiation of this study could influence Gilead Sciences’ stock performance positively, as successful trials may lead to new treatment options for solid tumors, enhancing the company’s market position. Investors should monitor this development alongside competitors’ advancements in oncology treatments.
The study is currently not yet recruiting, with further updates available on the ClinicalTrials portal.