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Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT04221542 · Amgen
In plain English
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Official title
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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.
1. Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
2. 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:
1. 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).
2. Dose-expansion phase: at least 1 prior NHT must have been given; 0-1 prior PARP inhibitors are acceptable.
3. 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:
1. 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.
2. No prior treatment with any chemotherapy regimen in the mCRPC setting; ≤ 6 cycles of docetaxel treatment in the mHSPC setting is allowed.
3. 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:
1. PSA level ≥ 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
2. Nodal or visceral progression as defined by RECIST v1.1 with PCGW3 modifications.
3. 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:
1. Hematological function:
1. absolute neutrophil count ≥ 1 x 10\^9/L (without growth factor support within 7 days from screening assessment).
2. platelet count ≥ 75 x 10\^9/L (without platelet transfusion within 7 days from screening assessment).
3. hemoglobin ≥ 9 g/dL (90 g/L) (without blood transfusion within 7 days from screening assessment).
2. Renal function:
1\. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation ≥ 30 ml/min/1.73 m\^2.
3. Hepatic function:
1. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN) (or \< 5 x ULN for participants with liver involvement).
2. total bilirubin (TBL) \< 1.5 x ULN (or \< 2 x ULN for participants with liver metastases).
4. Cardiac function:
1. left ventricular ejection fraction \> 50% (2-D transthoracic echocardiogram \[ECHO\] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not available).
2. Baseline electrocardiogram (ECG) QTcF ≤ 470 msec (average of triplicate values).
5. Pulmonary function:
1. baseline oxygen saturation \> 92% on room air at rest and no oxygen supplementation.
Part 3-Retreatment group:
* Deriving benefit from initial treatment with AMG 509 as evidenced by one of the following:
1. confirmed PSA50 response.
2. radiographic stable disease/partial response/complete response during 6 cycles of initial treatment with AMG 509 and without progression during the first 6 cycles.
* 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.
Key Exclusion Criteria:
* 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.
Study design
Enrollment target: 479 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-03-04
Estimated completion: 2032-03-21
Last updated: 2026-03-30
Interventions
Drug: AMG 509Drug: AbirateroneDrug: Enzalutamide
Primary outcomes
- • Parts 1-5 and 7: Incidence of Treatment-emergent Adverse Events (3 years)
- • Parts 1-5 and 7: Incidence of Treatment-related Adverse Events (3 years)
- • Parts 1-5 and 7 Dose Exploration Cohorts Only: Dose Limiting Toxicities (DLTs) (28 days)
Sponsor
Amgen · industry
With: BeiGene, BeOne (China only)
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (57)
City of Hope National Medical CenterRecruiting
Duarte, California, United States
Providence Saint Jude Medical CenterRecruiting
Fullerton, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
Rocky Mountain Cancer CentersRecruiting
Aurora, Colorado, United States
Yale New Haven HospitalRecruiting
New Haven, Connecticut, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
Indiana UniversityRecruiting
Indianapolis, Indiana, United States
MidAmerica Cancer CareRecruiting
Merriam, Kansas, United States
Tulane Medical CenterCompleted
New Orleans, Louisiana, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Duke UniversityRecruiting
Durham, North Carolina, United States
Wake Forest University Health SciencesRecruiting
Winston-Salem, North Carolina, United States
Oncology Hematology Care IncorporatedRecruiting
Cincinnati, Ohio, United States
Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
Prisma Health UpstateCompleted
Greenville, South Carolina, United States
Sanford Oncology Clinic and PharmacyRecruiting
Sioux Falls, South Dakota, United States
United States Oncology Regulatory Affairs Corporate OfficeRecruiting
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
US Oncology Research Investigational Products CenterRecruiting
Irving, Texas, United States
Intermountain Medical CenterRecruiting
Murray, Utah, United States
Virginia Cancer Specialists PCRecruiting
Fairfax, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Chris OBrien LifehouseRecruiting
Camperdown, New South Wales, Australia
Monash Medical CentreRecruiting
Clayton, Victoria, Australia
Peking University First HospitalRecruiting
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer CenterRecruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangxi, China
Fudan University Shanghai Cancer CentreRecruiting
Shanghai, Shanghai Municipality, China
Zhejiang Provincial Peoples HospitalRecruiting
Hangzhou, Zhejiang, China
Nanjing Drum Tower HospitalRecruiting
Nanjing, China
The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, China
Universitaetsklinikum EssenRecruiting
Essen, Germany
Universitaetsklinikum HeidelbergRecruiting
Heidelberg, Germany
Klinikum rechts der Isar der TUMRecruiting
München, Germany
Universitaetsklinikum MuensterRecruiting
Münster, Germany
National Cancer Center Hospital EastRecruiting
Kashiwa-shi, Chiba, Japan
Yokohama City University HospitalRecruiting
Yokohama, Kanagawa, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
Koto-ku, Tokyo, Japan
Hospital da Luz, SARecruiting
Lisbon, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa MariaRecruiting
Lisbon, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPERecruiting
Porto, Portugal
Seoul National University HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Hospital Universitari Vall d HebronRecruiting
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de BarcelonaRecruiting
Barcelona, Catalonia, Spain
Clinica Universidad de NavarraRecruiting
Pamplona, Navarre, Spain
Hospital Clinico San CarlosRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Istituto Oncologico della Svizzera ItalianaRecruiting
Bellinzona, Switzerland
Kantonsspital GraubuendenRecruiting
Chur, Switzerland
Centre Hospitalier Universitaire VaudoisRecruiting
Lausanne, Switzerland
Kantonsspital Sankt GallenRecruiting
Sankt Gallen, Switzerland
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical FoundationRecruiting
Taoyuan District, Taiwan