Clarity Pharmaceuticals has secured investigational new drug approval (IND) from the U.S. Food and Drug Administration (FDA) to start a phase II clinical trial of a radiotracer for detecting cancer in asymptomatic patients.
The clearance is for Clarity's SAR-Bombesin agent, which detects prostate cancer in men who are prostate specific membrane antigen (PSMA)-negative, according to the firm. The trial, called Copper-64 SAR-Bombesin in Biochemical REcurrence of Prostate Cancer trial (SABRE), will include up to 50 PSMA-negative men who have biochemical recurrence of the disease after surgery or radiation.
