IDEAYA Biosciences announces first-patient-in for phase 1 clinical trial evaluating IDE397 and Trodelvy combination in MTAP-deletion bladder cancer

James Spargo | June 27, 2024 | News story | Research and Development IDEAYA Biosciences, Oncology, bladder cancer, clinical trials, oncology 

Precision medicine oncology company IDEAYA Biosciences has announced that the first patient in the IDEAYA-sponsored phase 1 trial has been dosed. The trial evaluates 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.

 IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients with solid tumours that have methylthioadenosine phosphorylase (MTAP) deletion.

IDE397 as a monotherapy, or in combination with Trodelvy, has not been approved by any regulatory agency and the efficacy and safety of this combination has not yet been established. 

Included in an ongoing arm of IDEAYA-sponsored clinical trial, the IDE397 and Trodelvy combination phase 1 study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy. The IDEAYA-sponsored clinical trial includes a phase 2 expansion arm of IDE397 monotherapy in MTAP-deletion solid tumours.

“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,” commented Dr Darrin M Beaupre MD PhD, chief medical officer of IDEAYA Biosciences.

“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,” added Dr Beaupre.

Natalia Elliot

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