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.

Trial Details

NCT ID
NCT04221542
Phase
PHASE1
Sponsor
Amgen
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • AMG 509
  • Abiraterone
  • Enzalutamide
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Fullerton, California, United States|33.87029,-117.92534
  • San Francisco, California, United States|37.77493,-122.41942
  • Aurora, Colorado, United States|39.72943,-104.83192
  • New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

  • Parts 1, 2, 5 and 7: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are re…
  • Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
  • Dose-expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemi…
  • Part 3: Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (abiraterone acetate, enzalutamide…

For full eligibility, visit ClinicalTrials.gov.

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