Trials / Recruiting
RecruitingNCT04221542
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 479 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 509 | AMG 509 administered as an IV infusion (Parts 1, 3, 4 and 5) or SC injection (Part 2). |
| DRUG | Abiraterone | Abiraterone administered as oral tablets. |
| DRUG | Enzalutamide | Enzalutamide administered as oral tablets. |
Timeline
- Start date
- 2020-03-04
- Primary completion
- 2030-03-22
- Completion
- 2032-03-21
- First posted
- 2020-01-09
- Last updated
- 2026-03-30
Locations
57 sites across 10 countries: United States, Australia, China, Germany, Japan, Portugal, South Korea, Spain, Switzerland, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04221542. Inclusion in this directory is not an endorsement.