XYone Therapeutics Initiates First-in-Human Clinical Trial for Novel Cancer Drug XYA02
XYone Therapeutics, a clinical-stage biotechnology company based in greater Boston, MA, has announced that the first patient has been dosed in its first-in-human Phase 1b/2 clinical trial for XYA02 (also known as AT2021). XYA02 is a novel antibody-drug conjugate (ADC) specifically designed to target MUC1-C, a protein expressed across various solid tumors. The multicenter, open-label study aims to evaluate the safety and tolerability of XYA02, determine appropriate dose levels for future clinical development, and assess its pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. The trial includes patients with advanced, relapsed, and/or refractory solid tumors, specifically non-small cell lung, ovarian, gastric/GEJ, and colorectal cancers. The U.S. Food and Drug Administration (FDA) has already granted XYA02 Orphan Drug Designation (ODD) for the treatment of pancreatic cancer and gastric cancer.