NEW YORK – CARsgen Therapeutics said on Friday that it will begin evaluating its investigational monoclonal antibody AB011 combined with Roche's checkpoint inhibitor Tecentriq (atezolizumab) as first-line treatment for Claudin18.2 (CLDN18.2)-positive advanced gastric cancer patients in China.
China's National Medical Products Administration has cleared CARsgen's investigational new drug application to begin the Phase I trial in China. The trial will include patients with unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer whose tumors express CLDN18.2.
Through the trial, CARsgen will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AB011 plus Tecentriq. The firm has already begun evaluating AB011 as a monotherapy and combined with chemotherapy.
CARsgen has also been conducting a China-based clinical trial of its autologous CAR T-cell therapy CT041 for CLDN18.2-positive gastric and gastroesophageal junction cancers. That Phase II trial is enrolling patients who received at least two prior lines of treatment.