Phase I/IIa clinical evaluation of the novel peptide drug ATX-101 in patients with advanced cancer.

Offentlig prosjektsammendrag

APIM Therapeutics is currently developing ATX-101, an investigational anti-cancer agent based on a novel mechanism of action highly relevant for cancer escape and resistance. In preclinical studies, ATX-101 potentiates the actions of several anti-cancer agents across multiple solid tumor indications. Moreover, it shows single agent activity in blood cancers such as multiple myeloma. Having successfully completed all regulatory authority-mandated safety and toxicology studies, ATX-101 will enter first-in-man clinical testing in 2018. This testing aims to provide pivotal safety and efficacy data on ATX-101 and its mechanism of action as required for its continuous clinical development. The first trial to be conducted involves patients with advanced solid tumors (phase I). Upon conclusion of the first phase I part, a subsequent trial extension arm is planned in patients with advanced multiple myeloma (phase IIa). Following these initial trials, ATX-101 will enter subsequent clinical testing targeting as lead indications metastatic bladder cancer and multiple myeloma.