What is AMG 509 studying for metastatic castration-resistant prostate cancer?

AMG 509 is being studied to understand its safety, tolerability, pharmacokinetics, and early effectiveness in treating metastatic castration-resistant prostate cancer. The trial, sponsored by Amgen, evaluates AMG 509 alone and with other hormonal therapies to explore new treatment options for this condition. Participants may receive different doses and combinations as part of the study.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 years or older with metastatic castration-resistant prostate cancer who have received prior novel hormonal therapies and taxane chemotherapy may be eligible. Participants must have an adequate health status and organ function, and be on continuous androgen-deprivation therapy or have had bilateral orchiectomy. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal expenses such as travel or lodging may vary and are not guaranteed to be covered. Participants should plan accordingly for these potential costs.

Actively Recruiting

Phase 1

Age: 18Years +

MALE

ID04221542

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer

Led by Amgen · Updated on 2026-05-29

479

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating AMG 509 in participants with metastatic castration-resistant prostate cancer mCRPC to study its safety, tolerability, pharmacokinetics, and preliminary efficacy. The trial is a phase 1 interventional study sponsored by Amgen and includes participants who have previously been treated with novel hormonal therapies and taxane chemotherapy. Parts 4A expansion, 6, and 7 are currently open for enrollment as of mid-2025. The study includes multiple parts exploring different dosing methods and combinations. AMG 509 is given as an intravenous IV infusion in most parts and as a subcutaneous SC injection in one part. Some parts test AMG 509 alone, while others combine it with oral drugs abiraterone acetate or enzalutamide. Dose exploration phases aim to find the maximum tolerated dose or recommended phase 2 dose, with some parts enrolling participants from China to evaluate safety and dosing. The trial also includes outpatient infusion settings and focuses on participants with varying prior treatment histories. Participants undergo extensive monitoring including assessments of adverse events, vital signs, ECG, laboratory tests, and tumor response using RECIST criteria. The study measures pharmacokinetics such as serum concentration levels over time and evaluates prostate-specific antigen PSA responses and progression-free survival. The total duration for outcome monitoring can be up to three years for many measures. Participants organ functions and performance status are evaluated to ensure eligibility and safety throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Male participants aged 18 years or older
Histologically or cytologically confirmed metastatic castration-resistant prostate cancer
Prior treatment with novel hormonal therapies (e.g., abiraterone acetate, enzalutamide, apalutamide, or darolutamide) and 1 to 2 taxane regimens, or medically unsuitable/refusal of taxane treatment
Bilateral orchiectomy or continuous androgen-deprivation therapy with GnRH agonist or antagonist
Total serum testosterone ≤ 50 ng/dL or 1.7 nmol/L
Evidence of progressive disease according to Prostate Cancer Working Group 3 criteria
Eastern Cooperative Oncology Group performance status of 0 or 1
Life expectancy of at least 3 months
Adequate organ function including hematological, renal, hepatic, cardiac, and pulmonary parameters
For Part 3 retreated participants: prior benefit from AMG 509 initial treatment and willingness to have a fresh tumor biopsy if needed

You will not qualify if you...

Small cell or neuroendocrine carcinoma or other prostate cancer histology different from adenocarcinoma
Radiation therapy within 4 weeks prior to first dose (2 weeks for local or focal radiotherapy)
Untreated central nervous system metastases or leptomeningeal disease
Major surgery within 4 weeks prior to first dose
Active systemic infection within 7 days prior to first dose except controlled simple infections
History or current autoimmune disease requiring permanent immunosuppressive therapy
Recent history of arterial or venous thrombosis within specified timeframes
Myocardial infarction or symptomatic congestive heart failure within 12 months prior
Anti-cancer therapy or immunotherapy within 4 weeks prior to first dose (excluding LHRH/GnRH analogues)
Prior PSMA radionuclide therapy within 2 months prior to AMG 509 (with specific part restrictions)

Research Team

Amgen Call Center

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