NG001 Phase 0/1 theragnostic study in patients with metastatic castration resistant prostate cancer

Offentlig prosjektsammendrag

Patients suffering from metastatic castration resistant prostate cancer (mCRPC) is a patient group with unmet medical needs. Nucligen's product candidate, Pb-212-NG001, is a small molecular prostate-specific membrane antigen (PSMA) seeking radioligand for targeted alpha particle therapy for late-stage metastatic prostate cancer expressing PSMA. Preclinical data indicate good tumor targeting in vitro and in vivo with potent antitumor activity compared with other analogue products. In this project Nucligen will carry out early stage clinical development (Phase 0/1) of Pb-212-NG001 to prepare the product for later stage clinical development. The proiect also includes the development of an efficient manufacturing process for the drug, compliant with regulatory requirements (GMP).