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Prostate CancerPhase 1NCT04221542

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

A Phase 1 study testing AMG 509, Abiraterone and Enzalutamide in people with Prostate Cancer, run by Amgen at 57 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
AMG 509, Abiraterone and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
479 participants
Where
57 sitesin 10 countries
Study dates
4 Mar 2020to 21 Mar 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 45Show fewer
  • 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.
  • 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:
  • absolute neutrophil count ≥ 1 x 10^9/L (without growth factor support within 7 days from screening assessment).
  • platelet count ≥ 75 x 10^9/L (without platelet transfusion within 7 days from screening assessment).
  • hemoglobin ≥ 9 g/dL (90 g/L) (without blood transfusion within 7 days from screening assessment).
  • Renal function:
  • 1. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation ≥ 30 ml/min/1.73 m^2.
  • Hepatic function:
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (or < 5 x ULN for participants with liver involvement).
  • total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for participants with liver metastases).
  • Cardiac function:
  • 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).
  • Baseline electrocardiogram (ECG) QTcF ≤ 470 msec (average of triplicate values).
  • Pulmonary function:
  • 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:
  • confirmed PSA50 response.
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

57 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

57 sites in 10 countries

United States25 sites, 21 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

    Recruiting

  • Oncology Hematology Care Incorporated

    Cincinnati, Ohio, 45242

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031

    Recruiting

  • Providence Saint Jude Medical Center

    Fullerton, California, 92835

    Recruiting

  • Prisma Health Upstate

    Greenville, South Carolina, 29605

    Completed

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Recruiting

  • US Oncology Research Investigational Products Center

    Irving, Texas, 75063

    Recruiting

  • MidAmerica Cancer Care

    Merriam, Kansas, 66204

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Recruiting

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

    Recruiting

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

    Completed

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Terminated

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94158

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Sanford Oncology Clinic and Pharmacy

    Sioux Falls, South Dakota, 57104

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27103

    Terminated

Other trials in United States

China7 sites, 7 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Recruiting

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang, 314408

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210003

    Recruiting

  • Fudan University Shanghai Cancer Centre

    Shanghai, Shanghai Municipality, 200032

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

Other trials in China

Spain5 sites, 5 recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

    Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

    Recruiting

Other trials in Spain

Germany4 sites, 4 recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

    Recruiting

  • Klinikum rechts der Isar der TUM

    München, 81675

    Recruiting

  • Universitaetsklinikum Muenster

    Münster, 48149

    Recruiting

Other trials in Germany

Switzerland4 sites, 4 recruiting

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500

    Recruiting

  • Kantonsspital Graubuenden

    Chur, 7000

    Recruiting

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

    Recruiting

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007

    Recruiting

Other trials in Switzerland

Japan3 sites, 3 recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

    Recruiting

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

    Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

    Recruiting

Other trials in Japan

Portugal3 sites, 3 recruiting

  • Hospital da Luz, SA

    Lisbon, 1500-650

    Recruiting

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

    Lisbon, 1649-035

    Recruiting

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

    Recruiting

Other trials in Portugal

Australia2 sites, 2 recruiting

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050

    Recruiting

  • Monash Medical Centre

    Clayton, Victoria, 3168

    Recruiting

Other trials in Australia

South Korea2 sites, 2 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Asan Medical Center

    Seoul, 138-736

    Recruiting

Other trials in South Korea

Taiwan2 sites, 2 recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Recruiting

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

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
Prostate Cancer
Being tested
AMG 509, Abiraterone, Enzalutamide
Keywords
AMG 509, mCRPC, Metastatic Castration-resistant Prostate Cancer, Prostate cancer, PSMA, STEAP1, STEAP1 targeted therapy, Solid tumor, Immunotherapy, Immuno-oncology, Immunooncology, Bispecific T-Cell engager®, BiTE®, XmAb®
Medical subject headings
Prostatic Neoplasms, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 509Drug

    Also called xaluritamig

    AMG 509 administered as an IV infusion (Parts 1, 3, 4 and 5) or SC injection (Part 2).

  • AbirateroneDrug

    Abiraterone administered as oral tablets.

  • EnzalutamideDrug

    Enzalutamide administered as oral tablets.

Study groups in NCT04221542
Study groupRoleWhat they receive
Part 1: AMG 509 Intravenous (IV) MonotherapyExperimentalPart 1 will evaluate AMG 509 in participants with metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with novel hormonal therapy (NHT) and 1 to 2 prior taxanes. The dose exploration phase of the study will estimate the maximum tolerated dose (MTD) of AMG 509 using a Bayesian logistic regression model (BLRM; Neuenschwander et al, 2008). Recommended phase 2 dose (RP2D) may be identified based on emerging safety, efficacy, PK, and pharmacodynamics (PD) data, as well as patient experience prior to reaching an MTD. Alternative dosing schedule(s) (including a third step dose) may be explored based on emerging efficacy, safety, PK data and patient experience. During the dose-expansion phase, individual cohorts of participants from China will be enrolled with a safety lead-in at 1 dose level below the MTD or RP2D followed by evaluation at the MTD or RP2D to confirm the safety, tolerability, MTD and/or RP2D of AMG 509 in Chinese participants.
Receives: Drug: AMG 509
Part 2: AMG 509 Subcutaneous (SC) MonotherapyExperimentalPart 2 will explore the safety, tolerability, and PK of AMG 509 SC dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes. Recommended phase 2 dose for SC monotherapy may be identified based on emerging safety, efficacy, PK, and PD data, as well as patient experience prior to reaching an MTD.
Receives: Drug: AMG 509
Part 3: AMG 509 IV Monotherapy in Earlier Lines of TreatmentExperimentalPart 3 will explore AMG 509 in participants with mCRPC who have received no, or 1-2 prior NHTs (may have been given for hormone-sensitive prostate cancer [HSPC]) and no prior taxanes (unless administered in HSPC setting). This dose-expansion will be conducted to confirm safety, PK, and PD of AMG 509 at the MTD or RP2D determined in Part 1 dose exploration, and to obtain further safety and efficacy data and correlative biomarker analysis.
Receives: Drug: AMG 509
Part 4: AMG 509 IV Combination TherapyExperimentalPart 4 will explore the safety, tolerability, and PK of AMG 509 for participants with mCRPC who have received no or 1 to 2 prior NHTs given in any disease setting depending on the part (dose-expansion phase: prior therapies including at least 1 prior NHT and either 0 or 1 prior poly-ADP ribose polymerase [PARP] inhibitor), at dose regimens previously determined to be safe and tolerable in Part 1, in combination with abiraterone acetate (Part 4A) or enzalutamide (Part 4B) and no or 1 prior taxane for hormone sensitive disease in Parts 4A and 4B.
Receives: Drug: AMG 509; Drug: Abiraterone; Drug: Enzalutamide
Part 5: AMG 509 IV Monotherapy in Outpatient SettingExperimentalPart 5 will evaluate the safety and tolerability of AMG 509 IV dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes, when administered in outpatient infusion centers. The Part 5 dosing regimen and schedule was selected based on emerging data and dose level review team (DLRT) recommendations and will utilize the doses explored in Part 1 dose-expansion phase.
Receives: Drug: AMG 509
Part 6: AMG 509 IV as Monotherapy and Combination Therapy With Abiraterone AcetateExperimentalPart 6 will evaluate the preliminary efficacy, safety, tolerability, and PK of AMG 509 (alone or in combination with abiraterone acetate) for participants with mCRPC who have progressed on only 1 prior NHT (prior exposure to ≤ 6 cycles of taxane is allowed in mHSPC setting) and who have Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable disease. Part 6 dosing regimen has been previously determined as safe and tolerable and is aligned with the dosing schedule for Parts 3 and 4A expansion.
Receives: Drug: AMG 509; Drug: Abiraterone
Part 7 (China only): AMG 509 IV as Monotherapy or in Combination With Abiraterone AcetateExperimentalPart 7 will only include participants from China. This part will evaluate safety and tolerability of AMG 509 IV dosing in participants who have been previously treated with NHT and 1 to 2 prior taxanes. Part 7 dosing regime will first be enrolled to dose level-1 (1.0 mg target dose) and if tolerated and if DLRT determines it is safe to escalate to the MTD/RP2D, 1.5 mg every 2 weeks (Q2W) dosing regimen may be explored. If the RP2D is safe and tolerable and once AMG 509 monotherapy dose confirmation is complete, a cohort of participants to receive AMG 509 combination therapy with abiraterone acetate may be initiated.
Receives: Drug: AMG 509; Drug: Abiraterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts 1-5 and 7: Incidence of Treatment-emergent Adverse Events

    Measured: 3 years

  2. Parts 1-5 and 7: Incidence of Treatment-related Adverse Events

    Measured: 3 years

  3. Parts 1-5 and 7 Dose Exploration Cohorts Only: Dose Limiting Toxicities (DLTs)

    Measured: 28 days

  4. Parts 1-5 and 7: Number of Participants with Changes in Vital Signs

    Measured: 3 years

  5. Parts 1-5 and 7: Number of Participants with Changes in Electrocardiogram (ECG) Records

    Measured: 3 years

  6. Parts 1-5 and 7: Number of Participants with Changes in Clinical Laboratory Test Results

    Measured: 3 years

  7. Part 6: Objective Response (OR) per RECIST v1.1

    Measured: 3 years

Secondary outcomes (32)

  1. Parts 1-7: Maximum Serum Concentration (Cmax) for AMG 509

    To characterize the pharmacokinetics (PK) of AMG 509

    Measured: 3 years

  2. Parts 1-7: Time to Maximum Serum Concentration (Tmax) for AMG 509

    To characterize the pharmacokinetics (PK) of AMG 509

    Measured: 3 years

  3. Parts 1-7: Minimum Serum Concentration (Cmin) for AMG 509

    To characterize the pharmacokinetics (PK) of AMG 509

    Measured: 3 years

  4. Parts 1-7: Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for AMG 509

    To characterize the pharmacokinetics (PK) of AMG 509

    Measured: 3 years

  5. Parts 1-7: Accumulation Following Multiple Dosing for AMG 509

    To characterize the pharmacokinetics (PK) of AMG 509

    Measured: 3 years

  6. Parts 1-5 and 7: OR per RECIST v1.1

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  7. Parts 1-7: Prostate Specific Antigen (PSA) Response

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  8. Parts 1-5 and 7: PSA Decline of at Least 50% From Baseline at 12 Weeks

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: Week 12

  9. Parts 1-7: Radiographic Duration of Response (DOR)

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  10. Parts 1-5 and 7: PSA DOR

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  11. Parts 1-5 and 7: Radiographic Time to Progression

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  12. Parts 1-5 and 7: PSA Time to Progression

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  13. Parts 1-5 and 7: Radiographic Progression-free Survival (PFS)

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  14. Parts 1-5 and 7: PSA PFS

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  15. Part 6: Radiographic PFS per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  16. Parts 1-2, 5 and 7: 6 Month Radiographic PFS

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 6 months

  17. Part 3 and 4: 1, 2, and 3-year Radiographic PFS

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: Year 1, 2, and 3

  18. Parts 1-5: 1, 2, and 3-year Overall Survival (OS)

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: Year 1, 2, and 3

  19. Parts 1-5: Circulating Tumor Cells Response (CTC0)

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  20. Parts 1-5: Rate of Circulating Tumor Cells (CTC) Conversion

    To evaluate preliminary anti-tumor activity of AMG 509

    Measured: 3 years

  21. Parts 1-5: Time to Symptomatic Skeletal Events

    To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.

    Measured: 3 years

  22. Parts 1-5: Alkaline Phosphatase (Total, Bone)

    To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.

    Measured: 3 years

  23. Parts 1-5: Lactate Dehydrogenase (LDH)

    To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.

    Measured: 3 years

  24. Parts 1-5: Hemoglobin

    To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.

    Measured: 3 years

  25. Parts 1-5: Urine N-telopeptide

    To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.

    Measured: 3 years

  26. Parts 1-5: Neutrophil-to-lymphocyte Ratio

    To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.

    Measured: 3 years

  27. Part 6: Incidence of Treatment-emergent Adverse Events

    Measured: 3 years

  28. Part 6: Incidence of Treatment-related Adverse Events

    Measured: 3 years

  29. Part 6: Number of Participants with Changes in Vital Signs

    Measured: 3 years

  30. Part 6: Number of Participants with Changes in Clinical Laboratory Test Results

    Measured: 3 years

  31. Part 6: Disease Control per RECIST v1.1

    Measured: 3 years

  32. Parts 6 and 7: OS

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2020
  2. Study start4 Mar 2020
  3. Primary completion22 Mar 2030 (estimated)
  4. Study completion21 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
479 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04221542
Sponsor's protocol ID
20180146
Other IDs
2023-504361-23, 2023
Status last verified
Aug 2026
First submitted
16 Dec 2019
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Kelly WK, Danila DC, Lin CC, Lee JL, Matsubara N, Ward PJ, Armstrong AJ, Pook D, Kim M, Dorff TB, Fischer S, Lin YC, Horvath LG, Sumey C, Yang Z, Jurida G, Smith KM, Connarn JN, Penny HL, Stieglmaier J, Appleman LJ. Xaluritamig, a STEAP1 x CD3 XmAb 2+1 Immune Therapy for Metastatic Castration-Resistant Prostate Cancer: Results from Dose Exploration in a First-in-Human Study. Cancer Discov. 2024 Jan 12;14(1):76-89. doi: 10.1158/2159-8290.CD-23-0964.

    PubMed 37861461

  • Kuipers-Connarn JN, Pourzanjani A, Bose M, Modi S, Stieglmaier J, Murphy A, Mehta K, Upreti VV. Clinical Pharmacology Characterization and Dose Selection of Xaluritamig, a Next Generation XmAb(R) 2+1 T-Cell Engager, in Prostate Cancer Patients. J Clin Pharmacol. 2025 Dec;65(12):1676-1686. doi: 10.1002/jcph.70074. Epub 2025 Aug 5.

    PubMed 40765197

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 509, Abiraterone and Enzalutamide in people with Prostate Cancer, run by Amgen at 57 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, China, Spain, Germany, Switzerland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts 1-5 and 7: Incidence of Treatment-emergent Adverse Events (time frame: 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04221542, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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