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IDEAYA Biosciences Announces First-Patient-In for Phase 1 Clinical Trial Evaluating IDE397 and Trodelvy® Combination in MTAP-Deletion Bladder Cancer
First-Patient-In (FPI) for Phase 1 combination treatment with IDE397, IDEAYA's MAT2A inhibitor, and Trodelvy®, Gilead's Trop-2 directed antibody-drug
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"First-Patient-In (FPI) for Phase 1 combination treatment with IDE397, IDEAYA's MAT2A inhibitor, and Trodelvy®, Gilead's Trop-2 directed antibody-drug conjugate (ADC)The global Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with TrodelvyMTAP-deletion is found in approximately 26% of patients with bladder cancerSOUTH SAN FRANCISCO, Calif., June 25, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that it has dosed its first patient in the IDEAYA-sponsored Phase 1 trial evaluating the combination of IDE397, IDEAYA's investigational MAT2A inhibitor, and Trodelvy® (sacituzumab govitecan-hziy), Gilead's Trop-2 directed ADC, in patients with MTAP-deletion bladder cancer.\n\n \n \n \n \n \n \n\n \n\"We are pleased to have dosed our first patient with MTAP-deletion bladder cancer in this Phase 1 trial evaluating combination treatment with IDE397 and Trodelvy. The MAT2A-Trop2 ADC combination targets two distinct, yet complementary nodes in patients with MTAP-deleted urothelial cancer and has first-in-class potential to improve clinical outcomes for bladder cancer patients with poor prognosis associated with MTAP-deletion,\" commented Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. \nThe IDE397 and Trodelvy combination Phase 1 trial is included as an arm of an ongoing IDEAYA-sponsored clinical trial (NCT04794699), which includes a Phase 2 expansion arm of IDE397 monotherapy in MTAP-deletion solid tumors. The global Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with Trodelvy. IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion.\nGilead's Trodelvy is currently approved in nearly 50 countries for 2L metastatic triple-negative breast cancer and in more than 30 countries for pre-treated HR+/HER2- metastatic breast cancer (mBC). In the U.S., Trodelvy has an accelerated approval for the treatment of patients with locally advanced or metastatic urothelial cancer...