The open-label clinical trial, registered as NCT07670312, focuses on patients battling advanced non-small cell lung, ovarian, gastric, and colorectal cancers. Researchers are currently escalating doses to establish the safety profile, pharmacokinetic data, and preliminary antitumor efficacy of the drug, which utilizes an Exatecan payload. The study aims to refine therapeutic dosing before expanding into specific tumor cohorts.

XYone’s leadership emphasizes that targeting the tumor-anchored MUC1-C domain offers a strategic advantage over traditional MUC1-N approaches, which are often hindered by heterogeneous glycosylation. The U.S. Food and Drug Administration has already granted XYA02 Orphan Drug Designation for both pancreatic and gastric cancer, underscoring the potential for this modality in difficult-to-treat malignancies. While the drug remains investigational, the company expects these initial trials to clarify its role within their broader pipeline of T-cell engagers and antibody-drug conjugates.