Lay Title: A study using the research drug AMG 160 to treat your prostate cancer
Technical Title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen (PSMA) Half Life Extended (HLE) Bispecific T-cell Engager (BiTE) AMG 160 in Subjects with Metastatic Castration Resistant Prostate Cancer (mCRPC)
Disease Type: Metastatic, castration-resistant prostate cancer
Basic information: The purpose of this study is to see if the study drug, AMG160, is safe and tolerable and whether it causes any side effects. This study will also see what doses of AMG160 are safe for people to take, and how it affects metastatic prostate cancer. As part of this study, patients will also receive 68Ga-PSMA-11 PET/CT scans. The tracer for these scans are investigational and not FDA approved. AMG 160 is in a group of drugs called BiTE®antibodies.
Research Procedures (not a complete list): Each treatment cycle on this study is 4 weeks long. AMG160 will be given to you every 2 weeks per cycle through your vein (IV infusion).
You will need to be hospitalized for at least 72 hours after each infusion of the first cycle, at least 48 hours after the first infusion in the second cycle and at least 24 hours for the following infusion in the second cycle. You also will need to stay in the hospital or outpatient clinic for at least 4 hours after each infusion of cycles 3 and 4. Additional hospitalization or visits may be required for safety reasons. This infusion schedule may change if a drug dose is found to have certain side effects. After the first two cycles, you will return to clinic every 2 weeks for treatment, a doctor’s visit, and for safety assessments. You will also need to return for scans every 8-12 weeks.
Eligibility Criteria (not a complete list):
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