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    Summary
    EudraCT Number:2020-001305-23
    Sponsor's Protocol Code Number:20190505
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-31
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2020-001305-23
    A.3Full title of the trial
    A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer
    A.4.1Sponsor's protocol code number20190505
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04631601
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medican Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6301
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAMG 160
    D.3.2Product code AMG 160
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPending
    D.3.9.2Current sponsor codeAMG 160
    D.3.9.3Other descriptive nameAMG 160
    D.3.9.4EV Substance CodeSUB194531
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.28
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAMG 404
    D.3.2Product code AMG 404
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPending
    D.3.9.2Current sponsor codeAMG 404
    D.3.9.3Other descriptive nameAMG 404
    D.3.9.4EV Substance CodeSUB195317
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Castration-resistant Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    All subprotocols
    To evaluate the safety, tolerability, and maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of investigational therapies in subjects with metastatic castration-resistant prostate cancer (mCRPC)

    Subprotocol C Part 3 only
    •To evaluate preliminary anti-tumor activity of AMG 404 monotherapy
    E.2.2Secondary objectives of the trial
    All subprotocols
    •To evaluate preliminary anti-tumor activity of investigational therapies in subjects with mCRPC
    •To characterize the pharmacokinetics (PK) of investigational therapies in subjects with mCRPC

    Subprotocol C part 3 only
    • Safety: To evaluate the safety and tolerability of AMG 404 monotherapy
    • Efficacy: To evaluate anti-tumor activity of AMG 404 monotherapy with additional measures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All Subprotocols
    - Subjects with mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate without pure neuroendocrine differentiation or small cell features
    - Subjects must have undergone bilateral orchiectomy or must be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist.
    - Total serum testosterone ≤ 50 ng/dL (or 1.7 nmol/L)
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 – 1
    - Life expectancy of > 3 months
    - Adequate organ function, defined as follows:
    • absolute neutrophil count ≥ 1.5 x 10^9/L (without growth factor support within 7 days from screening assessment)
    • platelet count ≥ 100 x 10^9/L (without platelet transfusion within 7 days from screening assessment)
    • hemoglobin > 9 g/dL (90 g/L) (subprotocol A, C & D) / > 10 g/dL (100g/L) (subprotocol B) (without blood transfusion within 7 days from screening assessment)
    • estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 30 mL/min/1.73 m2
    • AST and ALT < 3 x upper limit of normal (ULN) (or < 5 x ULN for subjects with liver involvement)
    • total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for subjects with liver metastases)
    • left ventricular ejection fraction (LVEF)> 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) QTc ≤ 470 msec

    Subprotocol A & B only
    - Subjects planning to receive enzalutamide (subprotocol A) / abiraterone (subprotocol B) for the first time for mCRPC (subjects who received prior enzalutamide (subprotocol A) / abiraterone (subprotocol B) are not eligible).

    Subprotocol C only
    - Subjects who are refractory to a novel antiandrogen therapy (abiraterone, apalutamide, and/or enzalutamide) given for metastatic or non-metastatic prostate cancer. Subjects must be ineligible for or refuse taxane therapy.
    - Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
    • PSA level of at least 1 ng/mL that has risen on at least 2 successive occasions at least 1 week apart
    • nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications
    • appearance of 2 or more new lesions in bone scan

    Subprotocol D only
    - Subjects may have had novel hormonal therapies (NHT; eg, abiraterone, enzalutamide, apalutamide or darolutamide) for prostate cancer, but no more than 1 NHT for metastatic prostate cancer.
    - Subjects must be ineligible for or refuse taxane therapy.
    E.4Principal exclusion criteria
    All Subprotocols
    - CNS metastases/leptomeningeal disease
    - Symptomatic peripheral sensory/motor neuropathy ≥grade3
    - History/presence of clinically relevant CNS pathology
    - Confirmed history/current autoimmune disease or other diseases resulting in permanent immunosuppression/requiring permanent immunosuppressive therapy
    - Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials (Subprotocol A, B&D) /active fungal, bacterial, viral, or other infection requiring systemic therapy (Subprotocol C) within 7days of dosing
    - History/evidence of inflammatory bowel disease or any other GI disorder causing chronic nausea, vomiting, or diarrhea
    - History of arterial/venous thrombosis within 12months of 1st dose
    - Myocardial infarction, uncontrolled hypertension (Subprotocol A, C&D), unstable angina, cardiac arrhythmia requiring medication, &/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months (Subprotocol A,B&D) /within 6months (Subprotocol C) of 1st dose of AMG 160
    - Unresolved toxicities from prior anti-tumor therapy not having resolved to CTCAE version 5.0 grade 1, except for alopecia or toxicities that are stable and well-controlled & there is agreement to allow by both the investigator & sponsor
    - Known HIV infection, hepatitis C or hepatitis B infection
    - History of other malignancy within the past 2years, with the following exceptions:
    • Malignancy treated with curative intent & with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by treating physician
    • Adequately treated non-melanoma skin cancer/lentigo maligna without evidence of disease
    • Adequately treated urothelial papillary noninvasive carcinoma/carcinoma in situ
    - Prior treatment with a taxane for mCRPC
    - Radiation therapy within 4weeks of 1st dose (or local or focal radiotherapy within 2 weeks)
    - Any anticancer therapy/immunotherapy within 4 weeks (2 weeks Subprotocol C) of start of 1st dose, not including LHRH/GnRH analogue. Subjects on a stable bisphosphonate/denosumab regimen for ≥30 days prior to enrollment are eligible
    - Prior PSMAxCD3 bispecific therapy (not subprotocol C part 3)
    - Requiring chronic systemic corticosteroid therapy/any other immunosuppressive therapies. Low dose corticosteroids permitted
    - Prior major surgery within 4 weeks of 1st dose
    - Currently receiving treatment in another investigational device/drug study, or <4 weeks since ending treatment on another investigational device or drug study
    - Male subjects with a female partner of childbearing potential/pregnant partner who are unwilling to practice sexual abstinence/use contraception during treatment and for an additional 4 months (Subprotocol A,B&D) /8 months (Subprotocol C) after the last dose
    - Male subjects unwilling to abstain from donating sperm during treatment and for an additional 4 months (Subprotocol A,B&D) /8 months (Subprotocol C) after the last dose
    - Subject has known sensitivity to any of the products (or components) to be administered during dosing
    - Subject likely to not be available to complete all protocol-required study visits/procedures, &/or to comply with all required study procedures
    - History/evidence of any other clinically significant disorder, condition or disease (except for those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
    - History of SARS-CoV-2 infection unless agreed upon with medical monitor and:
    •negative test by RT-PCR within 72hours of 1st dose of AMG 160
    •no acute symptoms within 10days of 1st dose of AMG 160
    Subprotocol A
    - Use of strong CYP2C8 inhibitors within 7 days prior to 1st dose/strong CYP3A4 inducers within 28days
    - Use of narrow therapeutic index drugs that are substrates of CYP3A4, CYP2C9 or CYP2C19 prior to first dose and during study treatment.
    Subprotocol B
    - Baseline moderate & severe hepatic impairment
    - Presence of uncontrolled hypertension, hypokalemia, or fluid retention
    - History/presence of adrenocortical insufficiency
    - Use of concomitant medications that are sensitive substrates for CYP2D6 with a narrow therapeutic index within 7days
    - Use of strong CYP3A4 inducers within 28days
    Subprotocol C
    - History/evidence of interstitial lung disease or active, non-infectious pneumonitis
    - History of allergic reactions/acute hypersensitivity reaction to antibody therapies
    - Parts 1 & 2: Subjects on a prior PD-1/PD-L1 inhibitor who experienced a grade 3/higher immune-related AE prior to 1st day of dosing
    - Part 3: Subjects who have received a prior PD-1/PD-L1 inhibitor
    -Live vaccine therapy within 4 weeks prior to study drug administration
    - Prior allogeneic stem cell/solid organ transplantation
    For exclusion criteria specific to subprotocol D please refer to the document.
    E.5 End points
    E.5.1Primary end point(s)
    All subprotocols
    • treatment-emergent and treatment-related adverse events
    • changes in vital signs, and clinical laboratory tests

    Subprotocols A, B, C
    • dose-limiting toxicities (DLTs; dose exploration only)

    Subprotocol C Part 3
    • objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications
    • circulating tumor cell (CTC) response (CTC0 and CTC conversion)
    • prostate-specific antigen (PSA) response
    E.5.1.1Timepoint(s) of evaluation of this end point
    The analysis of all endpoints, unless noted otherwise, will be conducted on the Safety Analysis Set defined as all subjects that are enrolled and receive at least 1 dose of AMG 160 (or AMG 404 in Parts 1 and 2 and at least 1 dose of AMG 404 in Part 3 - Subprotocol C).
    E.5.2Secondary end point(s)
    All subprotocols
    • objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications
    • circulating tumor cell (CTC) response (CTC0 and CTC conversion)
    • prostate-specific antigen (PSA) response
    • duration of response (CTC, PSA, conventional radiographic per RECIST 1.1)
    • overall survival (OS)
    • progression-free survival (radiographic, PSA, clinical)
    • time to progression (radiographic, PSA)
    • time to subsequent therapy
    • prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) and 18F-fluorodeoxyglucose (FDG) PET/CT based response evaluation
    • other Prostate Cancer Working Group (PCWG3)-recommended endpoints (time to symptomatic skeletal events, alkaline phosphatase [total, bone], lactate dehydrogenase [LDH], hemoglobin, neutrophil to-lymphocyte ratio, urine N-telopeptide)
    • PK parameters including, but not limited to, maximum serum concentration (Cmax), minimum serum concentration (Cmin), area under the concentration-time curve (AUC) over the dosing interval, accumulation, and half-life (t1/2)

    Subprotocol C Part 3 only
    • treatment-emergent adverse events
    • treatment-related adverse events
    • changes in vital signs, and clinical laboratory tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    The analysis of all endpoints, unless noted otherwise, will be conducted on the Safety Analysis Set defined as all subjects that are enrolled and receive at least 1 dose of AMG 160 (or AMG 404 in Parts 1 and 2 and at least 1 dose of AMG 404 in Part 3 - Subprotocol C).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety, tolerability, PK, PD and efficacy - dose exploration and dose expansion
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV - The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), following any additional parts in the study (eg, long-term follow-up, additional antibody testing), as applicable.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 136
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-23
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