Amgen Terminates Phase I Trial of CLDN6/CD3 Bispecific AMG 794 Due to Strategic Commercial Decision

On July 8, according to the clinicaltrials.gov website, Amgen has terminated (TERMINATED) the Phase I clinical trial (NCT05317078) of CLDN6/CD3 bispecific antibody AMG 794 for the treatment of Claudin 6-positive non-small cell lung cancer, ovarian cancer, and other malignant solid tumors. The reason is "Amgen has made a commercial decision to terminate the development of AMG 794. The safety profile of AMG 794 remains unchanged."

This study was launched in February 2023, planning to recruit 98 patients, but only 3 were eventually recruited. The research centers are located in the United States, Australia, and Switzerland.

According to the PharmaCube database,Globally, no bispecific antibodies targeting CLDN6 have been approved for marketing, and currently, there are nine related bispecific antibodies under development. The main development directions can be divided into three categories: CLDN6/CD3 bispecific antibodies, CLDN6/4-1BB bispecific antibodies, and CLDN6/CLDN9 bispecific antibodies, all of which are in the early stages of research.

In the development of CLDN6/CD3 bispecific antibodies, in addition to Amgen's AMG 794, Chugai Pharmaceutical's SAIL66 has also entered Phase I clinical trials.

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