NEW YORK – Transcenta Holding said on Tuesday that it will begin a pivotal Phase III clinical trial of first-line osemitamab plus Bristol Myers Squibb's Opdivo (nivolumab) and chemotherapy in advanced or metastatic, HER2-negative, CLDN18.2-expressing gastric or gastroesophageal cancer.
The US Food and Drug Administration cleared an investigational new drug application for the firm to begin evaluating the second-generation CLDN18.2-targeting antibody osemitamab, also known as TST001, in the trial, dubbed TranStar 301.
Transcenta has previously conducted clinical trials of osemitamab combinations in both the US and China and believes the antibody has improved CLDN18.2-binding affinity and enhanced cytotoxicity versus standard of care for HER2-negative, CLDN18.2-expressing stomach cancer.
Suzhou, China-based Transcenta has already received approvals from China's Center for Drug Evaluation and South Korea's MFDS to conduct the pivotal trial in those regions.
The firm has also partnered with an unnamed US-based companion diagnostic developer to identify patients with CLDN18.2 expression who are eligible for osemitamab.