Ideaya announces first-patient-in for Phase 1 trial of IDE397 with Trodelvy

IDEAYA Biosciences (IDYA) has dosed its first patient in the IDEAYA-sponsored Phase 1 trial evaluating the combination of IDE397, IDEAYA’s investigational MAT2A inhibitor, and Trodelvy, Gilead’s (GILD) Trop-2 directed ADC, in patients with MTAP-deletion bladder cancer. The IDE397 and Trodelvy combination Phase 1 trial is included as an arm of an ongoing IDEAYA-sponsored clinical trial, 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 in patients having solid tumors with methylthioadenosine phosphorylase deletion. Gilead’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. In the U.S., Trodelvy has an accelerated approval for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and anti-PD-(L)1 therapy. Pursuant to the clinical study collaboration and supply agreement, IDEAYA and Gilead retain the commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent. IDEAYA is the study sponsor and Gilead will provide the supply of Trodelvy to IDEAYA.