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. Some patients will receive drugs called pembrolizumab or etanercept in addition to AMG160, to see if these combinations are safe and tolerable. As part of this study, patients will also receive 68Ga-PSMA-11 PET/CT scans.
AMG 160 is in a group of drugs called BiTE® antibodies. It is thought to work by stimulating the body’s immune system to kill cancer cells.
Pembrolizumab is another drug that helps the immune system kill cancer cells. It is approved to treat several different types of cancer, but is not approved to treat prostate cancer.
Etanercept is a drug for inflammatory conditions like rheumatoid arthritis. It is not approved for cancer treatment. It is being used in this study to see if it can reduce the inflammatory side effects of AMG160.
The study includes different arms with different treatment combinations and treatment settings (inpatient vs. outpatient). Please contact the study team to find out which arm is open for enrollment.
Research Procedures (not a complete list): Each treatment cycle on this study is 4 weeks long. AMG160 will be given every 2 weeks per cycle through your vein (IV infusion) unless you are enrolled into a cohort with step-dosing. If you are enrolled into a step-dosing cohort, check with the study team to determine the study drug dosing schedule.
If you are participating in an arm with pembrolizumab, pembrolizumab will be given every 4 weeks an IV infusion after the AMG160 has been administered.
If you are participating in an arm with etanercept, etanercept will be given as an injection two days before your AMG160 dose.
If you are participating in an arm that requires hospitalization for AMG160 dosing, you will need to be hospitalized for 2-3 days after each infusion of the first cycle and 1-2 after infusions in the second cycle. You may need additional hospitalizations/observation during later cycles for safety reasons.
If you are participating in an arm that requires outpatient dosing for AMG160, you may need to stay in the facility for up to 24 hours after your infusions. Additional hospitalization or visits may be required for safety reasons.
For all parts of the study, you will also need to return for scans every 8-12 weeks.
Eligibility Criteria (not a complete list):
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