A Phase 2, Open-Label, Multicenter Study of PSMA ADC in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
To assess the anti-tumor activity and tolerability of PSMA ADC in subjects with metastatic castration-resistant prostate cancer(mCRPC).
Must have confirmed prostate adenocarcinoma, must have been treated with at least 1 taxane-containing chemo regimen (e.g. docetaxel, cabazitaxel), must have received and progressed on abiraterone acetate and/or enzalutamide, must be at least 18 years of age, must have good physical status, must have good blood/kidney/liver functions, must have or be using some type of androgen-deprivation therapy, no history of pancreatitis, no history of clinically significant heart disease, no history of drug and/or alcohol abuse with five years of 1st dose of study drug.
PSMA ADC will be administered as an IV infusion over about 1 hour every 3 weeks for up to 8 doses. During dosing day, patients will have study bloods done and EKGs will be done before and after the infusion to monitor for side effects. Occasional surveys will be done to assess how the patient feels they are doing while on the study. Patients will be required to come to the clinic on day 15 (week 2) of every cycle to be evaluated. Cycles are 21 days (3 weeks) long. Scans will be done at the end of every 4 cycles to evaluate response.
12/19/2013 04:02 AM