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 a drug called pembrolizumab or etanercept in addition to AMG160, to see if these combinations aresafe and tolerable. 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.
The study will consist of 4 parts. In Part 1, patients will receive AMG160 alone in an inpatient (hospital) setting. In Part 2, patients will receive AMG160 in combination with pembrolizumab. In Part 3, patients will receive etanercept in combination with AMG160, to see if etanercept reduces the side effects of AMG160. In Part 4, patients will receive AMG160 alone in an outpatient (clinic) setting.
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.
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, you will be given AMG160 once per week for the first 3-4 weeks of Cycle 1. You will be dosed every 2 weeks thereafter.
If you are participating in Part 2 of the study, pembrolizumab will be given every 4 weeks an IV infusion after the AMG160 has been administered.
If you are participating in Part 3 of the study, etanercept will be given as an injection two days before your AMG160 dose.
In Parts 1 through 3, 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.
In Part 4, you will be monitored in the clinic for at least 24 hours after the Cycle 1 infusions, and for at least 4 hours in later cycles. Depending on your treatment group, you may need to take home an IV bag with study drug and have daily follow-up appointments. 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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Read more about this study (NCT03792841) on ClinicalTrials.gov.