OncoMatch/Clinical Trials/NCT04221542
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
Is NCT04221542 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including AMG 509 and Abiraterone for prostate cancer.
Treatment: AMG 509 · Abiraterone · Enzalutamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: antiandrogen (abiraterone acetate, enzalutamide, apalutamide, darolutamide) — mCRPC or as specified per cohort
refractory to a novel antiandrogen therapy (abiraterone acetate and/or enzalutamide, apalutamide, or darolutamide)
Cannot have received: radiation therapy
Exception: local or focal radiotherapy within 2 weeks of first dose
Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose)
Cannot have received: major surgery
Prior major surgery within 4 weeks of first dose
Cannot have received: anti-cancer therapy or immunotherapy
Exception: not including LHRH/GnRH analogue (agonist/antagonist)
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)
Cannot have received: PSMA radionuclide therapy
Exception: unless participant received < 2 cycles; 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
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.
Lab requirements
Blood counts
absolute neutrophil count ≥ 1 x 10^9/L (without growth factor support within 7 days from screening assessment); platelet count ≥ 75 x 10^9/L (without platelet transfusion within 7 days from screening assessment); hemoglobin ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment)
Kidney function
estimated glomerular filtration rate ≥ 30 ml/min/1.73 m^2
Liver function
AST and ALT < 3 x ULN (or < 5 x ULN for participants with liver involvement); total bilirubin < 1.5 x ULN (or < 2 x ULN for participants with liver metastases)
Cardiac function
left ventricular ejection fraction > 50% (2-D transthoracic echocardiogram preferred; multi-gated acquisition scan acceptable if ECHO not available); Baseline ECG QTcF ≤ 470 msec (average of triplicate values)
Adequate organ function, defined as follows: Hematological function: absolute neutrophil count ≥ 1 x 10^9/L (without growth factor support within 7 days from screening assessment); platelet count ≥ 75 x 10^9/L (without platelet transfusion within 7 days from screening assessment); hemoglobin ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment). Renal function: estimated glomerular filtration rate ≥ 30 ml/min/1.73 m^2. Hepatic function: AST and ALT < 3 x ULN (or < 5 x ULN for participants with liver involvement); total bilirubin < 1.5 x ULN (or < 2 x ULN for participants with liver metastases). Cardiac function: left ventricular ejection fraction > 50% (2-D transthoracic echocardiogram preferred; multi-gated acquisition scan acceptable if ECHO not available); Baseline ECG QTcF ≤ 470 msec (average of triplicate values). Pulmonary function: baseline oxygen saturation > 92% on room air at rest and no oxygen supplementation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Prisma Health Upstate · Greenville, South Carolina
- Sanford Oncology Clinic and Pharmacy · Sioux Falls, South Dakota
- United States Oncology Regulatory Affairs Corporate Office · Nashville, Tennessee
- University of Texas MD Anderson Cancer Center · Houston, Texas
- US Oncology Research Investigational Products Center · Irving, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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