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

Recruiting now · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04221542

Run by

Amgen

People needed

479

Starts

2020-03-04

Expected to finish

2032-03-21

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
• Dose-expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer 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:
• Participants with histologically or cytologically confirmed mCRPC who have received no or 1-2 prior NHTs (given in any disease setting depending on the part), and no or 1 taxane regimen (for HSPC).
• Dose-expansion phase: at least 1 prior NHT must have been given; 0-1 prior PARP inhibitors are acceptable.
• 4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible). Participants may have had exposure to up to 2 NHTs with a similar mechanism of action (apalutamide, enzalutamide or darolutamide) in the non-mCRPC and mCRPC setting.
• Dose-expansion phase: up to approximately 10 participants with prior exposure to abiraterone acetate may be enrolled into Part 4A expansion cohort.
• d. 4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide/apalutamide or daralutamide are not eligible).
• Part 6:
• Prior disease progression on 1, and only 1, NHT (either enzalutamide, apalutamide, or darolutamide) is required. NOTE: Prior progression on or intolerance to abiraterone is not allowed.
• No prior treatment with any chemotherapy regimen in the mCRPC setting; ≤ 6 cycles of docetaxel treatment in the mHSPC setting is allowed.
• mCRPC with ≥ 1 RECIST v1.1 measurable lesion that is present on baseline computed tomography (CT) or magnetic resonance imaging (MRI).
• 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:
• PSA level ≥ 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
• Nodal or visceral progression as defined by RECIST v1.1 with PCGW3 modifications.
• Appearance of 2 or more new lesions in bone scan.
• Eastern Cooperative Oncology Group performance status of 0-1.
• Life expectancy ≥ 3 months.
• Adequate organ function, defined as follows:
• Hematological function:

Where it is running

• Chris OBrien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
• Monash Medical Centre — Clayton, Victoria, Australia (enrolling)
• City of Hope National Medical Center — Duarte, California, United States (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• Providence Saint Jude Medical Center — Fullerton, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
• Oncology Hematology Care Incorporated — Cincinnati, Ohio, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• MidAmerica Cancer Care — Merriam, Kansas, United States (enrolling)
• Sanford Oncology Clinic and Pharmacy — Sioux Falls, South Dakota, United States (enrolling)
• United States Oncology Regulatory Affairs Corporate Office — Nashville, Tennessee, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• US Oncology Research Investigational Products Center — Irving, Texas, United States (enrolling)
• Intermountain Medical Center — Murray, Utah, United States (enrolling)
• Virginia Cancer Specialists PC — Fairfax, Virginia, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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