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TRO-01 is a novel antibody-drug conjugate (ADC) designed to target Claudin 18.2 (CLDN18.2), a protein specifically expressed in the gastric mucosa and frequently overexpressed in gastric, gastroesophageal junction (G/GEJ), and pancreatic adenocarcinomas. Developed by TriOar Inc., TRO-01 utilizes a fully human anti-CLDN18.2 monoclonal antibody conjugated to a topoisomerase I inhibitor payload via the proprietary TROSIG™ linker. This cleavable, stable, and hydrophilic linker technology allows for a high and uniform drug-to-antibody ratio (DAR) of 8. Preclinical data presented at AACR 2026 demonstrated that TRO-01 has high affinity and specificity for CLDN18.2, potent in vitro cytotoxicity, and significant anti-tumor efficacy in various xenograft models, including gastric and pancreatic patient-derived xenografts (PDX). Pharmacokinetic and toxicology studies in cynomolgus monkeys have shown favorable PK properties and a promising safety profile.
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