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RecruitingNCT04221542Updated Aug 21, 2026

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

A Phase 1 interventional study of AMG 509 and Abiraterone in Prostate Cancer, sponsored by Amgen. Recruiting at 57 sites in 10 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Amgen · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2020; still recruiting 6 years 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
479
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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®
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 479 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
479 participants (estimated)

Study arms

  • Experimental
    Part 1: AMG 509 Intravenous (IV) Monotherapy

    Part 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.

    Drug: AMG 509

  • Experimental
    Part 2: AMG 509 Subcutaneous (SC) Monotherapy

    Part 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.

    Drug: AMG 509

  • Experimental
    Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment

    Part 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.

    Drug: AMG 509

  • Experimental
    Part 4: AMG 509 IV Combination Therapy

    Part 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.

    Drug: AMG 509 · Drug: Abiraterone · Drug: Enzalutamide

  • Experimental
    Part 5: AMG 509 IV Monotherapy in Outpatient Setting

    Part 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.

    Drug: AMG 509

  • Experimental
    Part 6: AMG 509 IV as Monotherapy and Combination Therapy With Abiraterone Acetate

    Part 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.

    Drug: AMG 509 · Drug: Abiraterone

  • Experimental
    Part 7 (China only): AMG 509 IV as Monotherapy or in Combination With Abiraterone Acetate

    Part 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.

    Drug: AMG 509 · Drug: Abiraterone

Interventions

  • DrugAMG 509

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

    Also known as: xaluritamig

  • DrugAbiraterone

    Abiraterone administered as oral tablets.

  • DrugEnzalutamide

    Enzalutamide administered as oral tablets.

06

What researchers measure

Primary outcomes

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 28 days

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

Secondary outcomes

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

    To characterize the pharmacokinetics (PK) of AMG 509

    Time frame: 3 years

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

    To characterize the pharmacokinetics (PK) of AMG 509

    Time frame: 3 years

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

    To characterize the pharmacokinetics (PK) of AMG 509

    Time frame: 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

    Time frame: 3 years

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

    To characterize the pharmacokinetics (PK) of AMG 509

    Time frame: 3 years

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 3 years

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 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

    Time frame: Week 12

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 3 years

  10. Parts 1-5 and 7: PSA DOR

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 3 years

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 3 years

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 3 years

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 3 years

  14. Parts 1-5 and 7: PSA PFS

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 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

    Time frame: 3 years

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 6 months

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 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

    Time frame: Year 1, 2, and 3

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 3 years

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

    To evaluate preliminary anti-tumor activity of AMG 509

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

  32. Parts 6 and 7: OS

    Time frame: 3 years

07

Study locations

53 of 57 sites recruiting
  • City of Hope National Medical Center
    Duarte, California 91010, United States
    Recruiting
  • Providence Saint Jude Medical Center
    Fullerton, California 92835, United States
    Recruiting
  • University of California San Francisco
    San Francisco, California 94158, United States
    Recruiting
  • Rocky Mountain Cancer Centers
    Aurora, Colorado 80012, United States
    Recruiting
  • Yale New Haven Hospital
    New Haven, Connecticut 06520, United States
    Recruiting
  • Emory University
    Atlanta, Georgia 30322, United States
    Recruiting
  • Indiana University
    Indianapolis, Indiana 46202, United States
    Recruiting
  • MidAmerica Cancer Care
    Merriam, Kansas 66204, United States
    Recruiting
  • Tulane Medical Center
    New Orleans, Louisiana 70112, United States
    Completed
  • Washington University
    St Louis, Missouri 63110, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    Recruiting
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27103, United States
    Terminated
  • Oncology Hematology Care Incorporated
    Cincinnati, Ohio 45242, United States
    Recruiting
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15232, United States
    Recruiting
  • Prisma Health Upstate
    Greenville, South Carolina 29605, United States
    Completed
  • Sanford Oncology Clinic and Pharmacy
    Sioux Falls, South Dakota 57104, United States
    Recruiting
  • United States Oncology Regulatory Affairs Corporate Office
    Nashville, Tennessee 37203, United States
    Recruiting
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • US Oncology Research Investigational Products Center
    Irving, Texas 75063, United States
    Recruiting
  • Intermountain Medical Center
    Murray, Utah 84107, United States
    Recruiting
  • Virginia Cancer Specialists PC
    Fairfax, Virginia 22031, United States
    Recruiting
  • Virginia Oncology Associates
    Norfolk, Virginia 23502, United States
    Terminated
  • Fred Hutchinson Cancer Center
    Seattle, Washington 98109, United States
    Recruiting
  • Chris OBrien Lifehouse
    Camperdown, New South Wales 2050, Australia
    Recruiting
  • Monash Medical Centre
    Clayton, Victoria 3168, Australia
    Recruiting
  • Peking University First Hospital
    Beijing, Beijing Municipality 100034, China
    Recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
    Recruiting
  • Fudan University Shanghai Cancer Centre
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
  • Zhejiang Provincial Peoples Hospital
    Hangzhou, Zhejiang 314408, China
    Recruiting
  • Nanjing Drum Tower Hospital
    Nanjing, 210003, China
    Recruiting
  • The First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, 325000, China
    Recruiting
  • Universitaetsklinikum Essen
    Essen, 45147, Germany
    Recruiting
  • Universitaetsklinikum Heidelberg
    Heidelberg, 69120, Germany
    Recruiting
  • Klinikum rechts der Isar der TUM
    München, 81675, Germany
    Recruiting
  • Universitaetsklinikum Muenster
    Münster, 48149, Germany
    Recruiting
  • National Cancer Center Hospital East
    Kashiwa-shi, Chiba 277-8577, Japan
    Recruiting
  • Yokohama City University Hospital
    Yokohama, Kanagawa 236-0004, Japan
    Recruiting
  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
    Koto-ku, Tokyo 135-8550, Japan
    Recruiting
  • Hospital da Luz, SA
    Lisbon, 1500-650, Portugal
    Recruiting
  • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
    Lisbon, 1649-035, Portugal
    Recruiting
  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
    Porto, 4200-072, Portugal
    Recruiting
  • Seoul National University Hospital
    Seoul, 03080, South Korea
    Recruiting
  • Asan Medical Center
    Seoul, 138-736, South Korea
    Recruiting
  • Hospital Universitari Vall d Hebron
    Barcelona, Catalonia 08035, Spain
    Recruiting
  • Hospital Clinic i Provincial de Barcelona
    Barcelona, Catalonia 08036, Spain
    Recruiting
  • Clinica Universidad de Navarra
    Pamplona, Navarre 31008, Spain
    Recruiting
  • Hospital Clinico San Carlos
    Madrid, 28040, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
    Recruiting
  • Istituto Oncologico della Svizzera Italiana
    Bellinzona, 6500, Switzerland
    Recruiting
  • Kantonsspital Graubuenden
    Chur, 7000, Switzerland
    Recruiting
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, 1011, Switzerland
    Recruiting
  • Kantonsspital Sankt Gallen
    Sankt Gallen, 9007, Switzerland
    Recruiting
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
    Recruiting
  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
    Taoyuan, 33305, Taiwan
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04221542
Lead sponsor
Amgen
Collaborators
BeiGene, BeOne (China only)
Responsible party
Sponsor
First posted
Jan 9, 2020
Start date
Mar 4, 2020
Primary completion
Mar 22, 2030 (estimated)
Completion
Mar 21, 2032 (estimated)
Last update
Aug 21, 2026

Study contacts

Amgen Call Center
Contact
medinfo@amgen.com
866-572-6436
MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Prostatic Neoplasms→

Other studies from this sponsor

Amgen

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