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NCT04221542PHASE1Recruiting

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

Amgen

Start Date

3/4/2020

Completion Date

3/21/2032

Summary

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

AMG 509

DRUG

Abiraterone

DRUG

Enzalutamide

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Conditions

Prostate Cancer

Locations

City of Hope National Medical Center

Duarte, California 91010

United States

Providence Saint Jude Medical Center

Fullerton, California 92835

United States

University of California San Francisco

San Francisco, California 94158

United States

Rocky Mountain Cancer Centers

Aurora, Colorado 80012

United States

Yale New Haven Hospital

New Haven, Connecticut 06520

United States

Emory University

Atlanta, Georgia 30322

United States

Indiana University

Indianapolis, Indiana 46202

United States

MidAmerica Cancer Care

Merriam, Kansas 66204

United States

Tulane Medical Center

New Orleans, Louisiana 70112

United States

Washington University

St Louis, Missouri 63110

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27103

United States

Oncology Hematology Care Incorporated

Cincinnati, Ohio 45242

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15232

United States

Prisma Health Upstate

Greenville, South Carolina 29605

United States

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota 57104

United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee 37203

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

US Oncology Research Investigational Products Center

Irving, Texas 75063

United States

Intermountain Medical Center

Murray, Utah 84107

United States

Virginia Cancer Specialists PC

Fairfax, Virginia 22031

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Chris OBrien Lifehouse

Camperdown, New South Wales 2050

Australia

Monash Medical Centre

Clayton, Victoria 3168

Australia

Peking University First Hospital

Beijing, Beijing Municipality 100034

China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong 510060

China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

Fudan University Shanghai Cancer Centre

Shanghai, Shanghai Municipality 200032

China

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang 314408

China

Nanjing Drum Tower Hospital

Nanjing, 210003

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

Universitaetsklinikum Essen

Essen, 45147

Germany

Universitaetsklinikum Heidelberg

Heidelberg, 69120

Germany

Klinikum rechts der Isar der TUM

München, 81675

Germany

Universitaetsklinikum Muenster

Münster, 48149

Germany

National Cancer Center Hospital East

Kashiwa-shi, Chiba 277-8577

Japan

Yokohama City University Hospital

Yokohama, Kanagawa 236-0004

Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo 135-8550

Japan

Hospital da Luz, SA

Lisbon, 1500-650

Portugal

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, 1649-035

Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, 4200-072

Portugal

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 138-736

South Korea

Hospital Universitari Vall d Hebron

Barcelona, Catalonia 08035

Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia 08036

Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500

Switzerland

Kantonsspital Graubuenden

Chur, 7000

Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011

Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, 9007

Switzerland

National Taiwan University Hospital

Taipei, 10002

Taiwan

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Taoyuan, 33305

Taiwan