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Étude de l'AMG 509 chez des sujets atteints d'un cancer de la prostate métastatique résistant à la castration

6 novembre 2026 mis à jour par: Amgen

Une étude de phase 1 évaluant l'innocuité, la tolérance, la pharmacocinétique et l'efficacité de l'AMG 509 chez des sujets atteints d'un cancer de la prostate métastatique résistant à la castration

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 10.2 (31 Aug 2026), only Parts 6 and 7 are open to accrual.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

505

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Amgen Call Center
  • Numéro de téléphone: 866-572-6436
  • E-mail: medinfo@amgen.com

Lieux d'étude

  • Allemagne
      • Essen, Allemagne, 45147
        • Recrutement
        • Universitaetsklinikum Essen
      • Heidelberg, Allemagne, 69120
        • Recrutement
        • Universitaetsklinikum Heidelberg
      • München, Allemagne, 81675
        • Recrutement
        • Klinikum rechts der Isar der TUM
      • Münster, Allemagne, 48149
        • Recrutement
        • Universitaetsklinikum Muenster
  • Australie
    • New South Wales
      • Camperdown, New South Wales, Australie, 2050
        • Recrutement
        • Chris OBrien Lifehouse
    • Victoria
      • Clayton, Victoria, Australie, 3168
        • Recrutement
        • Monash Medical Centre
  • Chine
      • Nanjing, Chine, 210003
        • Recrutement
        • Nanjing Drum Tower Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100034
        • Recrutement
        • Peking University First Hospital
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510060
        • Recrutement
        • Sun Yat-sen University Cancer Center
    • Jiangxi
      • Nanchang, Jiangxi, Chine, 330006
        • Recrutement
        • The First Affiliated Hospital of Nanchang University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200127
        • Recrutement
        • Fudan University Shanghai Cancer Centre
    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 314408
        • Recrutement
        • Zhejiang Provincial Peoples Hospital
      • Wenzhou, Zhejiang, Chine, 325000
        • Recrutement
        • The First Affiliated Hospital of Wenzhou Medical University
  • Corée du Sud
      • Seoul, Corée du Sud, 03080
        • Recrutement
        • Seoul National University Hospital
      • Seoul, Corée du Sud, 138-736
        • Recrutement
        • Asan Medical Center
  • Espagne
      • Madrid, Espagne, 28041
        • Recrutement
        • Hospital Universitario 12 de Octubre
      • Madrid, Espagne, 28040
        • Recrutement
        • Hospital Clinico San Carlos
    • Catalonia
      • Barcelona, Catalonia, Espagne, 08036
        • Recrutement
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Catalonia, Espagne, 08035
        • Recrutement
        • Hospital Universitari Vall d Hebron
    • Navarre
      • Pamplona, Navarre, Espagne, 31008
        • Recrutement
        • Clinica Universidad de Navarra
  • Japon
    • Chiba
      • Kashiwa-shi, Chiba, Japon, 277-8577
        • Recrutement
        • National Cancer Center Hospital East
    • Kanagawa
      • Yokohama, Kanagawa, Japon, 236-0004
        • Recrutement
        • Yokohama City University Hospital
    • Tokyo
      • Koto-ku, Tokyo, Japon, 135-8550
        • Recrutement
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Le Portugal
      • Lisbon, Le Portugal, 1500-650
        • Recrutement
        • Hospital da Luz, SA
      • Lisbon, Le Portugal, 1649-035
        • Recrutement
        • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
      • Porto, Le Portugal, 4200-072
        • Recrutement
        • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
  • Suisse
      • Bellinzona, Suisse, 6500
        • Recrutement
        • Istituto Oncologico della Svizzera Italiana
      • Lausanne, Suisse, 1011
        • Recrutement
        • Centre Hospitalier Universitaire Vaudois
      • Sankt Gallen, Suisse, 9007
        • Recrutement
        • Kantonsspital Sankt Gallen
  • Taïwan
      • Taipei, Taïwan, 10002
        • Recrutement
        • National Taiwan University Hospital
      • Taoyuan, Taïwan, 33305
        • Recrutement
        • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
  • États-Unis
    • California
      • Duarte, California, États-Unis, 91010
        • Recrutement
        • City of Hope National Medical Center
      • Fullerton, California, États-Unis, 92835
        • Recrutement
        • Providence Saint Jude Medical Center
      • San Francisco, California, États-Unis, 94158
        • Recrutement
        • University of California San Francisco
    • Colorado
      • Denver, Colorado, États-Unis, 80218
        • Recrutement
        • Rocky Mountain Cancer Centers
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Recrutement
        • Emory University
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46202
        • Recrutement
        • Indiana University
    • Minnesota
      • Rochester, Minnesota, États-Unis, 55905
        • Complété
        • Tulane Medical Center
    • Missouri
      • Kansas City, Missouri, États-Unis, 64114
        • Recrutement
        • MidAmerica Cancer Care
      • St Louis, Missouri, États-Unis, 63110
        • Recrutement
        • Washington University
    • New York
      • New York, New York, États-Unis, 10065
        • Recrutement
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, États-Unis, 10032
        • Recrutement
        • Yale New Haven Hospital
    • North Carolina
      • Durham, North Carolina, États-Unis, 27710
        • Recrutement
        • Duke University Medical Center Duke Cancer Center
      • Winston-Salem, North Carolina, États-Unis, 27157
        • Résilié
        • Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45242
        • Recrutement
        • Oncology Hematology Care Incorporated
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Recrutement
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, États-Unis, 15232
        • Recrutement
        • University of Pittsburgh Medical Center
    • South Carolina
      • Greenville, South Carolina, États-Unis, 29605
        • Complété
        • Prisma Health Upstate
    • South Dakota
      • Sioux Falls, South Dakota, États-Unis, 57104
        • Recrutement
        • Sanford Oncology Clinic and Pharmacy
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • University of Texas MD Anderson Cancer Center
      • Irving, Texas, États-Unis, 75063
        • Résilié
        • Virginia Oncology Associates
    • Utah
      • Murray, Utah, États-Unis, 84107
        • Recrutement
        • Intermountain Medical Center
    • Virginia
      • Fairfax, Virginia, États-Unis, 22031
        • Recrutement
        • Virginia Cancer Specialists PC
    • Washington
      • Seattle, Washington, États-Unis, 98109
        • Recrutement
        • Fred Hutchinson Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Part 1: AMG 509 Intravenous (IV) Monotherapy

Participants with metastatic castration-resistant prostate cancer (mCRPC) receive AMG 509 (xaluritamig) by short-term IV infusion.
Médicament: AMG 509

AMG 509 administered as an IV infusion (Parts 1, 3, 4, 5, 6 and 7) or SC injection (Part 2).

Autres noms:
  • xaluritamig
Expérimental: Part 2: AMG 509 Subcutaneous (SC) Monotherapy

Participants with mCRPC receive AMG 509 by SC injection.
Médicament: AMG 509

AMG 509 administered as an IV infusion (Parts 1, 3, 4, 5, 6 and 7) or SC injection (Part 2).

Autres noms:
  • xaluritamig
Expérimental: Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment

Participants with mCRPC receive AMG 509 by IV infusion.
Médicament: AMG 509

AMG 509 administered as an IV infusion (Parts 1, 3, 4, 5, 6 and 7) or SC injection (Part 2).

Autres noms:
  • xaluritamig
Expérimental: Part 4: AMG 509 IV Combination Therapy

Participants with mCRPC receive AMG 509 by IV infusion with either oral abiraterone acetate (Part 4A), or oral enzalutamide (Part 4B).
Médicament: AMG 509

AMG 509 administered as an IV infusion (Parts 1, 3, 4, 5, 6 and 7) or SC injection (Part 2).

Autres noms:
  • xaluritamig
Médicament: Abiraterone

Abiraterone administered as oral tablets.

Médicament: Enzalutamide

Enzalutamide administered as oral tablets.
Expérimental: Part 5: AMG 509 IV Monotherapy in Outpatient Setting

Participants with mCRPC receive AMG 509 by IV infusion in an outpatient infusion setting.
Médicament: AMG 509

AMG 509 administered as an IV infusion (Parts 1, 3, 4, 5, 6 and 7) or SC injection (Part 2).

Autres noms:
  • xaluritamig
Expérimental: Part 6: AMG 509 IV as Monotherapy and Combination Therapy With Abiraterone Acetate

Participants with mCRPC and measurable disease are randomized 1:1 to receive either AMG 509 by IV infusion or AMG 509 with oral abiraterone acetate.
Médicament: AMG 509

AMG 509 administered as an IV infusion (Parts 1, 3, 4, 5, 6 and 7) or SC injection (Part 2).

Autres noms:
  • xaluritamig
Médicament: Abiraterone

Abiraterone administered as oral tablets.
Expérimental: Part 7 (China only): AMG 509 IV as Monotherapy or in Combination With Abiraterone Acetate

Participants in China receive AMG 509 by IV infusion as monotherapy or, if the combination cohort is initiated, with oral abiraterone acetate.
Médicament: AMG 509

AMG 509 administered as an IV infusion (Parts 1, 3, 4, 5, 6 and 7) or SC injection (Part 2).

Autres noms:
  • xaluritamig
Médicament: Abiraterone

Abiraterone administered as oral tablets.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Parties 1-5 et 7: Incidence des événements indésirables émergents du traitement
Délai: 3 ans
3 ans
Parties 1-5 et 7: Incidence des événements indésirables liés au traitement
Délai: 3 ans
3 ans
Parts 1-5 et 7 Cohorts d'exploration de dose uniquement: toxicités limitant la dose (DLT)
Délai: 28 jours
28 jours
Parties 1-5 et 7: nombre de participants avec des changements dans les signes vitaux
Délai: 3 ans
3 ans
Pièces 1-5 et 7: Nombre de participants avec des changements dans les dossiers de l'électrocardiogramme (ECG)
Délai: 3 ans
3 ans
Parties 1-5 et 7: Nombre de participants ayant des changements dans les résultats des tests de laboratoire cliniques
Délai: 3 ans
3 ans
Partie 6: Réponse objective (OR) par RECIST V1.1
Délai: 3 ans
3 ans

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Partie 6: Incidence des événements indésirables émergents du traitement
Délai: 3 ans
3 ans
Partie 6: Incidence des événements indésirables liés au traitement
Délai: 3 ans
3 ans
Partie 6: Nombre de participants ayant des changements dans les signes vitaux
Délai: 3 ans
3 ans
Partie 6: Nombre de participants ayant des changements dans les résultats des tests de laboratoire cliniques
Délai: 3 ans
3 ans
Partie 6: Contrôle des maladies par RECIST V1.1
Délai: 3 ans
3 ans
Parties 6 et 7: OS
Délai: 3 ans
3 ans
Parts 1-7: Maximum Serum Concentration (Cmax) for AMG 509
Délai: 3 years

To characterize the pharmacokinetics (PK) of AMG 509
3 years
Parts 1-7: Time to Maximum Serum Concentration (Tmax) for AMG 509
Délai: 3 years

To characterize the pharmacokinetics (PK) of AMG 509
3 years
Parts 1-7: Minimum Serum Concentration (Cmin) for AMG 509
Délai: 3 years

To characterize the pharmacokinetics (PK) of AMG 509
3 years
Parts 1-7: Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for AMG 509
Délai: 3 years

To characterize the pharmacokinetics (PK) of AMG 509
3 years
Parts 1-7: Accumulation Following Multiple Dosing for AMG 509
Délai: 3 years

To characterize the pharmacokinetics (PK) of AMG 509
3 years
Parts 1-5 and 7: OR per RECIST v1.1
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-7: Prostate Specific Antigen (PSA) Response
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-5 and 7: PSA Decline of at Least 50% From Baseline at 12 Weeks
Délai: Week 12

To evaluate preliminary anti-tumor activity of AMG 509
Week 12
Parts 1-7: Radiographic Duration of Response (DOR)
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-5 and 7: PSA DOR
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-5 and 7: Radiographic Time to Progression
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-5 and 7: PSA Time to Progression
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-5 and 7: Radiographic Progression-free Survival (PFS)
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-5 and 7: PSA PFS
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Part 6: Radiographic PFS per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-2, 5 and 7: 6 Month Radiographic PFS
Délai: 6 months

To evaluate preliminary anti-tumor activity of AMG 509
6 months
Part 3 and 4: 1, 2, and 3-year Radiographic PFS
Délai: Year 1, 2, and 3

To evaluate preliminary anti-tumor activity of AMG 509
Year 1, 2, and 3
Parts 1-5: 1, 2, and 3-year Overall Survival (OS)
Délai: Year 1, 2, and 3

To evaluate preliminary anti-tumor activity of AMG 509
Year 1, 2, and 3
Parts 1-5: Circulating Tumor Cells Response (CTC0)
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-5: Rate of Circulating Tumor Cells (CTC) Conversion
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509
3 years
Parts 1-5: Time to Symptomatic Skeletal Events
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
3 years
Parts 1-5: Alkaline Phosphatase (Total, Bone)
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
3 years
Parts 1-5: Lactate Dehydrogenase (LDH)
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
3 years
Parts 1-5: Hemoglobin
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
3 years
Parts 1-5: Urine N-telopeptide
Délai: 3 years

To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
3 years
Parts 1-5: Neutrophil-to-lymphocyte Ratio
Délai: 3 years

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Amgen

Collaborateurs

BeiGene
BeOne (China only)

Les enquêteurs

  • Directeur d'études: MD, Amgen

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 mars 2020

Achèvement primaire (Estimé)

28 juillet 2030

Achèvement de l'étude (Estimé)

29 juillet 2032

Dates d'inscription aux études

Première soumission

16 décembre 2019

Première soumission répondant aux critères de contrôle qualité

6 janvier 2020

Première publication (Réel)

9 janvier 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 20180146
  • 2023-504361-23 (Autre identifiant: EU CT Number)
  • 2023 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Critères d'accès au partage IPD

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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