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Trial record 1 of 1 for:    NCT03792841
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Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With mCRPC

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ClinicalTrials.gov Identifier: NCT03792841
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
A study to evaluate the safety and tolerability of AMG 160 in adult subjects with metastatic castration-resistant prostate cancer (mCRPC), and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Prostate Cancer Drug: AMG 160 Drug: Pembrolizumab Phase 1

Detailed Description:
This is a phase I, first-in-human study to evaluate the safety and tolerability of AMG 160, a half-life extended (HLE) bispecific T-cell engager (BiTE®) antibody, in subjects with metastatic castration-resistant prostate cancer.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager AMG 160 in Subjects With Metastatic Castration-resistant Prostate Cancer
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: AMG 160 Treatment
Part 1: AMG 160 is administered intravenously at different dose levels.
 Drug: AMG 160
Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer
Other Name: PSMA Targeted Therapy
Experimental: AMG 160 + Pembrolizumab
Part 2: AMG 160 is administered intravenously at different dose levels. Pembrolizumab will be administered intravenously at a dose of 200 mg.
 Drug: AMG 160
Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer
Other Name: PSMA Targeted Therapy

Drug: Pembrolizumab
Combined with AMG 160 for investigational treatment of mCRPC
Other Name: PD-1 inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with dose-limiting toxicity [ Time Frame: Up to 3 years ]
    Part 1 and 2 of the study

  2. Number of participants with treatment-emergent adverse events [ Time Frame: Up to 3 years ]
    For Parts 1 and 2 of the study

  3. Number of participants with treatment-related adverse events [ Time Frame: Up to 3 years ]
    For Parts 1 and 2 of the study

  4. Number of participants with clinically significant changes in vital signs [ Time Frame: Up to 3 years ]
    For Parts 1 and 2 of the study

  5. Number of participants with clinically significant changes in electrocardiogram (ECG) [ Time Frame: Up to 3 years ]
    For Parts 1 and 2 of the study

  6. Number of participants with clinically significant changes in clinical laboratory tests [ Time Frame: Up to 3 years ]
    For Parts 1 and 2 of the study


Secondary Outcome Measures :
  1. Part 1 and Part 2- Subject incidence of changes in pharmacokinetics - maximum serum concentration (Cmax) [ Time Frame: Up to 3 years ]
  2. Part 1 and 2 -Objective response (OR) [ Time Frame: Up to 3 years ]
  3. Part 1 and 2 - Prostate-specific antigen (PSA) response [ Time Frame: Up to 3 years ]
  4. Part 1 and 2 - Duration of response (DOR) (radiographic and PSA) [ Time Frame: Up to 3 years ]
  5. Part 1 and 2- Change in time to progression (radiographic and PSA) [ Time Frame: Up to 3 years ]
  6. Part 1 and 2 - 1, 2 and 3-year overall survival (OS) [ Time Frame: Up to 3 years ]
  7. Part 1 and 2 - Other PCWG3-recommended endpoints - time to symptomatic skeletal events [ Time Frame: Up to 3 years ]
  8. Part 1 and Part 2- Subject incidence of changes in pharmacokinetics - minimum serum concentration (Cmin) [ Time Frame: Up to 3 years ]
  9. Part 1 and Part 2- Subject incidence of changes in pharmacokinetics - area under the concentration-time curve (AUC) over the dosing interval [ Time Frame: Up to 3 years ]
  10. Part 1 and Part 2- Subject incidence of changes in pharmacokinetics - administration including accumulation following multiple dosing [ Time Frame: Up to 3 years ]
  11. Part 1 and Part 2- Subject incidence of changes in pharmacokinetics - half-life [ Time Frame: Up to 3 years ]
  12. Part 1 and 2 - Other PCWG3-recommended endpoints - lactate dehydrogenase [LDH] [ Time Frame: Up to 3 years ]
  13. Part 1 and 2 - Other PCWG3-recommended endpoints - hemoglobin [ Time Frame: Up to 3 years ]
  14. Part 1 and 2 - Other PCWG3-recommended endpoints - neutrophil-to-lymphocyte ratio [ Time Frame: Up to 3 years ]
  15. Part 1 and 2 - Other PCWG3-recommended endpoints - urine N-telopeptide [ Time Frame: Up to 3 years ]
  16. Part 1 and 2 - Other PCWG3-recommended endpoints alkaline phosphatase [total, bone] [ Time Frame: Up to 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Part 1 and Part 2

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures
  • Subjects with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting
  • Subject should have undergone bilateral orchiectomy or should be on continuous androgen-deprivation therapy (ADT) 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 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 1.1 with PCGW3 modifications, and/or appearance of 2 or more new lesions in bone scan

Exclusion Criteria:

  • Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue (agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for >/= 30 days prior to randomization are eligible
  • Prior PSMA-targeted therapy (subjects on prior 177Lu-PSMA-617 therapy may be eligible if discussed with Amgen medical monitor prior to enrollment)
  • Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
  • Active autoimmune disease or any other diseases requiring immunosuppressive therapy while on study
  • Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose

Part 2 only:

  • Subjects on a prior PD-1 or PD-L1 inhibitor who experienced a Grade 3 or higher immune-related adverse event prior to first day of dosing
  • History or evidence of interstitial lung disease or active, non-infectious pneumonitis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792841


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
Research Site Recruiting
Duarte, California, United States, 91010
United States, New York
Research Site Recruiting
New York, New York, United States, 10065
Australia, New South Wales
Research Site Recruiting
Camperdown, New South Wales, Australia, 2050
Research Site Recruiting
Randwick, New South Wales, Australia, 2031
Australia, Victoria
Research Site Recruiting
Parkville, Victoria, Australia, 3050
Austria
Research Site Recruiting
Salzburg, Austria, 5020
Belgium
Research Site Recruiting
Bruxelles, Belgium, 1200
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03792841    
Other Study ID Numbers: 20180101
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 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 (or other new use) 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.
Access Criteria: 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
AMG 160
HLE-BiTE®
mCRPC
Metastatic Castration-resistant Prostate Cancer
Prostate cancer
PSMA
BiTE®
 Bispecific T-Cell engager
Immunotherapy
Immuno-oncology
Immunooncology
Solid tumor
PSMA Targeted Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Prostatic Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents