FDA grants fast track designation to CMG901 for gastrointestinal cancers
The FDA granted fast track designation to CMG901 for treatment of certain patients with gastrointestinal cancers.
The designation applies to use of the agent by patients with unresectable or metastatic gastric or gastroesophageal junction cancers who relapsed after or are refractory to approved therapies.
CMG901 (Keymed Biosciences) is an antibody-drug conjugate that consists of three components: a monoclonal antibody that targets Claudin 18.2, a cleavable linker and a potent cytotoxic payload. Claudin 18.2 is a highly selective molecule widely expressed in solid tumors, including gastric cancer.
The FDA based the fast track designation on results of phase 1 studies that assessed the safety, tolerability, pharmacokinetics and preliminary efficacy of the agent.
The dose-escalation stage of a phase 1 clinical trial designed to evaluate CMG901 for patients with solid tumors is about to conclude, and a dose-expansion stage is anticipated to begin in the second quarter of this year.
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