Ideaya Biosciences has dosed the first subject in its Phase I clinical trial of IDE397 plus Trodelvy in patients with methylthioadenosine phosphorylase (MTAP)-deletion bladder cancer.
This trial is part of an ongoing IDEAYA-sponsored study that includes a Phase II expansion arm for IDE397 monotherapy in solid tumours with MTAP deletion.
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The global Phase I trial will assess the safety, efficacy, and tolerability of a combination regimen of IDE397 plus Trodelvy.
Developed by IDEAYA, IDE397 is a potent methionine adenosyltransferase 2 alpha (MAT2A) inhibitor for patients with solid tumours exhibiting MTAP deletion.
A Trop-2 directed antibody drug-conjugate (ADC) by Gilead, Trodelvy is approved in numerous countries for specific metastatic breast cancers. It also received accelerated approval in the US for certain urothelial cancers.
Under a clinical study collaboration and supply agreement, IDEAYA and Gilead will hold the commercial rights to their respective assets, including their use as single agent or as a combination regimen.
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By GlobalDataIDEAYA is serving as the sponsor of the trial while Gilead is offering the Trodelvy needed for the trial execution.
In addition, an Amgen-sponsored Phase I/II trial is assessing IDE397, along with AMG 193, for MTAP-Deletion NSCLC.
IDEAYA anticipates reporting data from approximately 15 evaluable patients for the IDE397 Phase II monotherapy expansion dose in MTAP-deletion bladder and lung cancer in the second half of this year.
IDEAYA Biosciences chief medical officer Dr Darrin Beaupre said: “We are pleased to have dosed our first patient with MTAP-deletion bladder cancer in this Phase I 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.”
In March this year, the company entered a clinical trial collaboration and supply agreement with MSD to evaluate the combination of IDE161 and Keytruda in a trial for the treatment of endometrial cancer.
