On July 11, 2019 IDEAYA Biosciences, Inc., an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported initiation of its Phase 1/2 study evaluating IDE196 in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions (ClinicalTrials.gov Identifier: NCT03947385) (Press release, Ideaya Biosciences, JUL 11, 2019, View Source [SID1234537497]). The first patient dosing was in June 2019 and clinical trial sites are now enrolling in the U.S. and Australia.
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IDEAYA previously announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for the development of IDE196 as a treatment for metastatic uveal melanoma and other solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations. "IDEAYA’s tissue-type agnostic strategy provides a genetic biomarker driven approach to treat patients whose tumors harbor GNAQ or GNA11 hotspot mutations across multiple solid tumors, including uveal melanoma, cutaneous melanoma, and colorectal cancer," said Meredith McKean, MD, MPH, Melanoma and Skin Cancer Research Program, Sarah Cannon Research Institute.
"We are delighted to announce our first patient dosing for IDE196 in our tissue type agnostic GNAQ and GNA11 basket trial, and the opportunity to advance IDE196 in its dose escalation with the goal of enabling the optimal dose selection for the Phase 2 portion of the trial," said Julie Hambleton, M.D., Chief Medical Officer, Head of Development at IDEAYA Biosciences.
IDE196 is a potent small molecule protein kinase C (PKC) inhibitor demonstrating clinical activity and tolerability in a separate ongoing Phase 1 trial of IDE196 in patients with Metastatic Uveal Melanoma (MUM). Approximately 90% of uveal melanoma patients harbor activating mutations in GNAQ or GNA11 (GNAQ/11). Mutations in GNAQ/11 have also been observed in other solid tumors, such as cutaneous melanoma, colorectal, pancreatic, stomach, cervical, lung adenocarcinoma and bladder. The clinical focus of IDEAYA’s Phase 1/2 basket trial will be on treatment of patients having tumors with likely pathogenic GNAQ/11 hotspot mutations, which are known to activate the PKC signaling pathway. GNAQ/11 hotspot mutations are not generally known to overlap with other oncogenic driver mutations, such as BRAF and NRAS mutations, in certain solid tumors.
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