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Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT04221542 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • BeOne (China only)

    collaborator UNKNOWN

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2030-03-22
Completion
2032-03-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Germany
  • Japan
  • Portugal
  • South Korea
  • Spain
  • Switzerland
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04221542 on ClinicalTrials.gov