New hope for Hard-to-Treat prostate cancer: early trial launches

NCT ID NCT04221542

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This early-stage study tests a new drug called AMG 509, alone or with other medicines, in people with a type of advanced prostate cancer that no longer responds to hormone therapy. The main goals are to check safety and how the body processes the drug. About 479 participants will take part. This is not a cure, but aims to control the disease.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 479 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Bites and Stings castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

53 sites in 10 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

Asan Medical Center
RECRUITING

Seoul, 138-736, South Korea
Centre Hospitalier Universitaire Vaudois
RECRUITING

Lausanne, 1011, Switzerland
Chris OBrien Lifehouse
RECRUITING

Camperdown, New South Wales, 2050, Australia
City of Hope National Medical Center
RECRUITING

Duarte, California, 91010, United States
Clinica Universidad de Navarra
RECRUITING

Pamplona, Navarre, 31008, Spain
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27710, United States
Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Fred Hutchinson Cancer Center
RECRUITING

Seattle, Washington, 98109, United States
Fudan University Shanghai Cancer Centre
RECRUITING

Shanghai, Shanghai Municipality, 200032, China
Hospital Clinic i Provincial de Barcelona
RECRUITING

Barcelona, Catalonia, 08036, Spain
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital Universitari Vall d Hebron
RECRUITING

Barcelona, Catalonia, 08035, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital da Luz, SA
RECRUITING

Lisbon, 1500-650, Portugal
Indiana University
RECRUITING

Indianapolis, Indiana, 46202, United States
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
RECRUITING

Porto, 4200-072, Portugal
Intermountain Medical Center
RECRUITING

Murray, Utah, 84107, United States
Istituto Oncologico della Svizzera Italiana
RECRUITING

Bellinzona, 6500, Switzerland
Kantonsspital Graubuenden
RECRUITING

Chur, 7000, Switzerland
Kantonsspital Sankt Gallen
RECRUITING

Sankt Gallen, 9007, Switzerland
Klinikum rechts der Isar der TUM
RECRUITING

München, 81675, Germany
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
RECRUITING

Taoyuan, 33305, Taiwan
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
MidAmerica Cancer Care
RECRUITING

Merriam, Kansas, 66204, United States
Monash Medical Centre
RECRUITING

Clayton, Victoria, 3168, Australia
Nanjing Drum Tower Hospital
RECRUITING

Nanjing, 210003, China
National Cancer Center Hospital East
RECRUITING

Kashiwa-shi, Chiba, 277-8577, Japan
National Taiwan University Hospital
RECRUITING

Taipei, 10002, Taiwan
Oncology Hematology Care Incorporated
RECRUITING

Cincinnati, Ohio, 45242, United States
Peking University First Hospital
RECRUITING

Beijing, Beijing Municipality, 100034, China
Prisma Health Upstate
COMPLETED

Greenville, South Carolina, 29605, United States
Providence Saint Jude Medical Center
RECRUITING

Fullerton, California, 92835, United States
Rocky Mountain Cancer Centers
RECRUITING

Aurora, Colorado, 80012, United States
Sanford Oncology Clinic and Pharmacy
RECRUITING

Sioux Falls, South Dakota, 57104, United States
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Sun Yat-sen University Cancer Center
RECRUITING

Guangzhou, Guangdong, 510060, China
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
RECRUITING

Koto-ku, Tokyo, 135-8550, Japan
The First Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING

Wenzhou, 325000, China
Thomas Jefferson University
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Tulane Medical Center
COMPLETED

New Orleans, Louisiana, 70112, United States
US Oncology Research Investigational Products Center
RECRUITING

Irving, Texas, 75063, United States
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
RECRUITING

Lisbon, 1649-035, Portugal
United States Oncology Regulatory Affairs Corporate Office
RECRUITING

Nashville, Tennessee, 37203, United States
Universitaetsklinikum Essen
RECRUITING

Essen, 45147, Germany
Universitaetsklinikum Heidelberg
RECRUITING

Heidelberg, 69120, Germany
Universitaetsklinikum Muenster
RECRUITING

Münster, 48149, Germany
University of California San Francisco
RECRUITING

San Francisco, California, 94158, United States
University of Pittsburgh Medical Center
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
University of Texas MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Virginia Cancer Specialists PC
RECRUITING

Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
TERMINATED

Norfolk, Virginia, 23502, United States
Wake Forest University Health Sciences
TERMINATED

Winston-Salem, North Carolina, 27103, United States
Washington University
RECRUITING

St Louis, Missouri, 63110, United States
Yale New Haven Hospital
RECRUITING

New Haven, Connecticut, 06520, United States
Yokohama City University Hospital
RECRUITING

Yokohama, Kanagawa, 236-0004, Japan
Zhejiang Provincial Peoples Hospital
RECRUITING

Hangzhou, Zhejiang, 314408, China

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