Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual.
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual. |
| Who can participate | Inclusion Criteria: * Parts 1, 2, 5 and 7: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are refractory to a novel antiandrogen therapy (abiraterone acetate and/or enzalutamide, apalutamide, or darolutamide) and have failed at least 1 (but not more than 2) taxane regimens including for metastatic hormone-sensitive prostate cancer (mHSPC) (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. Any NHT that has been administered and has been stopped for reasons other than progression will not be counted as an additional line of treatment. 1. Dose exploration pha |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Amgen |
| Locations | Duarte, California, United States; Fullerton, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States (+51 more sites) |
| Start date | 2020-03-04 |
| NCT ID | NCT04221542 |
| Official listing | https://clinicaltrials.gov/study/NCT04221542 |