Actively Recruiting
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
Led by Amgen · Updated on 2026-05-08
479
Participants Needed
57
Research Sites
628 weeks
Total Duration
On this page
Sponsors
A
Amgen
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Histologically or cytologically confirmed metastatic castration-resistant prostate cancer
- Refractory to or medically unsuitable for novel antiandrogen therapies including abiraterone acetate, enzalutamide, apalutamide, or darolutamide
- Failed at least one but no more than two taxane chemotherapy regimens or refused taxane treatment
- For dose-expansion phases, limited prior systemic anti-cancer treatments as specified
- Underwent bilateral orchiectomy or on continuous androgen-deprivation therapy with GnRH agonist or antagonist
- Total serum testosterone level of 50 ng/dL or less
- Evidence of progressive disease by PSA, imaging, or bone scan 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 as defined
- For Part 3-Retreatment group: prior benefit from AMG 509 initial treatment and willingness to have fresh tumor biopsy if needed
You will not qualify if you...
- Presence of small cell or neuroendocrine prostate carcinoma or any histology other than adenocarcinoma
- Radiation therapy within 4 weeks before first dose or local radiotherapy within 2 weeks
- Untreated central nervous system metastases or leptomeningeal disease
- Major surgery within 4 weeks before first dose
- Active systemic infection within 7 days prior to treatment, except certain controlled infections
- History or current autoimmune disease requiring permanent immunosuppressive therapy
- Recent arterial thrombosis within 12 months or venous thrombosis within 6 months unless stable on anticoagulation
- Myocardial infarction or symptomatic heart failure within 12 months, with some exceptions
- Recent anti-cancer or immunotherapy within 4 weeks before first dose, excluding certain hormone therapies
- Prior prostate specific membrane antigen radionuclide therapy within 2 months unless limited exposure
- For Part 3-Retreatment: any anti-cancer therapy after last AMG 509 dose except certain hormone or bone therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 57 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Providence Saint Jude Medical Center
Fullerton, California, United States, 92835
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
4
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
Actively Recruiting
5
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
MidAmerica Cancer Care
Merriam, Kansas, United States, 66204
Actively Recruiting
9
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
Completed
10
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
12
Duke University Medical Center Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
13
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
14
Oncology Hematology Care Incorporated
Cincinnati, Ohio, United States, 45242
Actively Recruiting
15
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
16
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
17
Prisma Health Upstate
Greenville, South Carolina, United States, 29605
Completed
18
Sanford Oncology Clinic and Pharmacy
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
19
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, United States, 37203
Actively Recruiting
20
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
21
US Oncology Research Investigational Products Center
Irving, Texas, United States, 75063
Actively Recruiting
22
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
23
Virginia Cancer Specialists PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
24
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
25
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
26
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
27
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
28
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
29
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
30
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
31
Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
32
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, China, 314408
Actively Recruiting
33
Nanjing Drum Tower Hospital
Nanjing, China, 210003
Actively Recruiting
34
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325000
Actively Recruiting
35
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
36
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
37
Klinikum rechts der Isar der TUM
München, Germany, 81675
Actively Recruiting
38
Universitaetsklinikum Muenster
Münster, Germany, 48149
Actively Recruiting
39
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
40
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
41
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
42
Hospital da Luz, SA
Lisbon, Portugal, 1500-650
Actively Recruiting
43
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
44
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Actively Recruiting
45
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
46
Asan Medical Center
Seoul, South Korea, 138-736
Actively Recruiting
47
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
48
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
49
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
50
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
51
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
52
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 6500
Actively Recruiting
53
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Actively Recruiting
54
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Actively Recruiting
55
Kantonsspital Sankt Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
56
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
57
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, Taiwan, 33305
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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