Phase 1 Study of Treatment for Advanced HER2-Positive Cancers Gets Underway

Phase 1 Study of Treatment for Advanced HER2-Positive Cancers Gets Underway
A Phase 1 clinical trial assessing the safety and efficacy of the anti-HER2 antibody ZW25 in advanced or metastatic HER2-positive cancers has just dosed its first patient, according to a recent announcement by Zymeworks, the therapy's manufacturer. “We are excited to have begun enrollment in this initial study of ZW25,” Diana Hausman, Zymeworks’ chief medical officer, said in a press release. “No approved HER2-targeted therapies exist for many patients with HER2-expressing cancers and with its unique mechanism of action, ZW25 has the potential to address this significant unmet need.” The trial (NCT02892123), which is currently recruiting participants, is an open-label, single-group study evaluating the safety and tolerability of ZW25 in patients with locally advanced, unresectable, or metastatic HER2-expressing cancers, including ovarian, breast, gastric, lung cancers. (More information about the trial is available on its clinical trials.gov website.) Each of the 30 patients expected to enter the study will receive once weekly, intravenous, escalating doses of ZW25, which will allow the researchers to identify the highest dose that can be administered without unacceptable side effects. Investigators are also seeking to determine the drug dose associated with optimal biologic activity. Zymeworks is developing protein-based therapeutics for the treatment of cancer, autoimmune, and inflammatory diseases. ZW25, its lead therapeutic bas
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