Study of AMG 509 for Metastatic Prostate Cancer
This study is testing a new drug called AMG 509, by itself or with other prostate cancer medicines like abiraterone and enzalutamide. Researchers want to see if AMG 509 is safe, how your body handles it, and if it helps treat metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and no longer responds to hormone therapy. You might be able to join if you are a man aged 18 or older with mCRPC that has worsened after certain hormone therapies and up to two chemotherapy treatments. The study is currently enrolling participants for specific parts (4A expansion, 6, and 7).
- Study design
- This is an interventional study with a planned enrollment of 479 participants. It is testing different ways to give AMG 509, including IV infusion and subcutaneous injection.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects for up to 3 years after treatment.
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NCT04221542
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentAmgen
~479 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:AMG 509AbirateroneEnzalutamide
At a glance
Recruiting sites
53 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts 1-5 and 7: Incidence of Treatment-emergent Adverse Events
Measured over 3 years
+6 more outcomes measured
Conditions
Where it's being run
57 sites across 38 statesGermany4
Switzerland4
California3
Portugal3
North Carolina2
Pennsylvania2
Texas2
Virginia2
Study leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Part 3: Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) given in any disease setting and who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen (unless taxane treatment was administered in HSPC setting). 0 1 prior PARP inhibitors or sipuleucel-T treatments are acceptable. Participants who received prior investigational therapy for the treatment of metastatic disease are not eligible.
Parts 4A, 4B and 7:
Dose-expansion phase: up to approximately 10 participants with prior exposure to abiraterone acetate may be enrolled into Part 4A expansion cohort.
Part 6:
All parts:
Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist.
Total serum testosterone ≤ 50 ng/dL or 1.7 nmol/L.
Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria:
Eastern Cooperative Oncology Group performance status of 0-1.
Life expectancy ≥ 3 months.
Adequate organ function, defined as follows:
Deriving benefit from initial treatment with AMG 509 as evidenced by one of the following:
No discontinuation for toxicity during the initial treatment with 6 cycles of AMG 509.
Progressive disease as defined in I106 within 12 months of final dose in their initial treatment with 6 cycles (EOT\_1).
Willingness to have a fresh tumor biopsy prior to initiating the additional course of treatment, depending on safety and feasibility as assessed by investigator.
Exclusion
Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.
Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).
Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
Prior major surgery within 4 weeks of first dose.
Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration. Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Screening for chronic infectious conditions is not required.
Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6 months and stable on anti-coagulation. Participants with a recent history of venous thrombosis must be maintained on the same anti-coagulation therapy for a minimum of 28 days prior to first dose of study treatment.
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of AMG 509.
Any anti-cancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone (LHRH)/GnRH analogue (agonist/antagonist).
Prior prostate specific membrane antigen (PSMA) radionuclide therapy within 2 months prior to AMG 509 unless participant received \< 2 cycles (Note: a participant cannot have received PSMA radionuclide therapy \< 35 days prior to enrollment if 1 cycle was given). Parts 3 and 4: prior PSMA radionuclide therapy is prohibited. Participants on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to enrollment are eligible (exception: part 3 retreatment).
Part 3-Retreatment only: Any anti-cancer therapy or immunotherapy, not including luteinizing hormone-releasing hormone/gonadotropin releasing hormone (LHRH/GnRH) analogue (agonist/antagonist), and/or bisphosphonate or denosumab regimen after last dose of AMG 509 initial course of treatment.
What this trial measures
- Parts 1-5 and 7: Incidence of Treatment-emergent Adverse Events3 years
- Parts 1-5 and 7: Incidence of Treatment-related Adverse Events3 years
- Parts 1-5 and 7 Dose Exploration Cohorts Only: Dose Limiting Toxicities (DLTs)28 days
- Parts 1-5 and 7: Number of Participants with Changes in Vital Signs3 years
- Parts 1-5 and 7: Number of Participants with Changes in Electrocardiogram (ECG) Records3 years
- Parts 1-5 and 7: Number of Participants with Changes in Clinical Laboratory Test Results3 years
- Part 6: Objective Response (OR) per RECIST v1.13 years