XYone Therapeutics First Patient Dosed in Phase 1b/2 Clinical Trial of XYA02

CANTON, Mass., Sept. 29, 2026 /CourierPR/ -- XYone Therapeutics Inc has taken a significant step in its clinical development pipeline with the dosing of the first patient in a Phase 1b/2 clinical trial of its lead antibody-drug conjugate, XYA02 (also known as AT2021). The multicenter, open-label study is evaluating XYA02 in patients with advanced, relapsed, and/or refractory solid tumors.

The clinical trial includes patients with advanced solid tumors in non-small cell lung, ovarian, gastric/GEJ, and colorectal cancers.

XYA02 is a novel MUC1-C targeting ADC for the treatment of multiple solid tumors. It was engineered with a novel, proprietary antibody conjugated with Exatecan payload. The company's pipeline includes multiple antibody-drug conjugates, T-cell engagers (TCEs), and other MUC1-C, directed therapeutic modalities.

The study will initially assess escalating doses of XYA02, followed by further evaluation in selected tumor types based on emerging safety, pharmacokinetic, biomarker, and antitumor activity data. The company's focus on developing innovative treatments for difficult-to-treat solid tumors underscores its commitment to advancing the field of oncology.

The first patient was dosed in the trial, which is being conducted at multiple centers. The study is expected to provide valuable insights into the safety and efficacy of XYA02, potentially paving the way for further clinical development and eventual commercialization.