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A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04702737
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE January 7, 2021
First Posted Date  ICMJE January 11, 2021
Last Update Posted Date October 15, 2021
Actual Study Start Date  ICMJE June 10, 2021
Estimated Primary Completion Date March 17, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
  • Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to 12 months ]
  • Number of Participants who Experience One or More Treatment-related Adverse Events [ Time Frame: Day 1 to 12 months ]
  • Number of Participants who Experience a Clinically Significant Change from Baseline in Vital Signs [ Time Frame: Baseline to 12 months ]
  • Number of Participants who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements [ Time Frame: Baseline to 12 months ]
  • Number of Participants who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests [ Time Frame: Baseline to 12 months ]
  • Number of Participants who Experience Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
  • Objective Response (OR) [ Time Frame: Baseline to 12 months ]
    OR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications.
  • Duration of Response (DOR) [ Time Frame: Baseline to 12 months ]
  • Progression-free Survival (PFS) [ Time Frame: Baseline to 12 months ]
  • Overall Survival (OS) [ Time Frame: Baseline to 12 months ]
  • Disease Control Rate (DCR) [ Time Frame: Baseline to 12 months ]
  • Maximum Serum Concentration (Cmax) of AMG 757 [ Time Frame: Baseline to 12 months ]
  • Minimum Serum Concentration (Cmin) of AMG 757 [ Time Frame: Baseline to 12 months ]
  • Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 757 [ Time Frame: Baseline to 12 months ]
  • Accumulation Ratio of AMG 757 [ Time Frame: Baseline to 12 months ]
  • Half-life (t1/2) of AMG 757 [ Time Frame: Baseline to 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
  • Objective Response (OR) [ Time Frame: Baseline to 12 months ]
    OR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications.
  • Duration of Response (DOR) [ Time Frame: Baseline to 12 months ]
  • Progression-free Survival (PFS) [ Time Frame: Baseline to 12 months ]
  • Overall Survival (OS) [ Time Frame: Baseline to 12 months ]
  • Maximum Serum Concentration (Cmax) of AMG 757 [ Time Frame: Baseline to 12 months ]
  • Minimum Serum Concentration (Cmin) of AMG 757 [ Time Frame: Baseline to 12 months ]
  • Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 757 [ Time Frame: Baseline to 12 months ]
  • Accumulation Ratio of AMG 757 [ Time Frame: Baseline to 12 months ]
  • Half-life (t1/2) of AMG 757 [ Time Frame: Baseline to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer
Official Title  ICMJE A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Delta-like Protein 3 Half-life Extended Bispecific T-cell Engager AMG 757 in Subjects With De Novo or Treatment Emergent Neuroendocrine Prostate Cancer
Brief Summary To evaluate the safety and tolerability of AMG 757 and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Neuroendocrine Prostate Cancer
Intervention  ICMJE Drug: AMG 757
AMG 757 will be administered as an intravenous (IV) infusion.
Study Arms  ICMJE
  • Experimental: Part 1: Dose Exploration
    The maximum tolerated dose (MTD) will be estimated using isotonic regression (Ji et al, 2010). The recommended phase 2 dose (RP2D) may be identified based on emerging safety data prior to reaching an MTD.
    Intervention: Drug: AMG 757
  • Experimental: Part 2: Dose Expansion
    Participants will received the recommended phase 2 dose (RP2D) identified in Part 1 (dose exploration) of the study.
    Intervention: Drug: AMG 757
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 12, 2025
Estimated Primary Completion Date March 17, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Men aged ≥ 18 years at time of signing the informed consent.
  • Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) defined by histological, immunohistochemistry, or genomic analyses of baseline tumor tissue (by local assessment) or circulating tumor DNA (ctDNA) (by local assessment) as per protocol
  • At least 1 line of prior systemic treatment per protocol.
  • For participants with treatment-emergent NEPC or de novo NEPC with histologic evidence of prostate cancer with neuroendocrine differentiation.
  • Participants with treatment-emergent NEPC or de novo NEPC with histologic evidence of prostate cancer with neuroendocrine differentiation without a history of bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue therapy during the course of protocol therapy
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Prostate Cancer Working Group 3 (PCWG3) modifications
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
  • Participants with treated brain metastases are eligible provided they meet defined criteria
  • Adequate organ function as defined in protocol

Exclusion Criteria:

  • History of other malignancy within the past 2 years, with exceptions:

    • Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated non-muscle invasive urothelial carcinoma
  • History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥ 2 years
  • Untreated or symptomatic brain metastases and leptomeningeal disease
  • Anti-tumor therapy within 28 days of study day 1; concurrent use of hormone deprivation therapy for hormone refractory prostate is permitted; participants on a stable bisphosphonate or denosumab for ≥ 30 days prior to study day 1 are eligible

Exceptions:

  • Participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicities have resolved to Grade ≤ 1
  • Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757
  • Participants who received androgen signaling inhibitor are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade ≤ 1

    • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior study day 1
    • Active autoimmune disease requiring systemic treatment within the past 2 years
    • Known positive test for human immunodeficiency virus (HIV) or hepatitis
    • Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade 0 or 1 (with the exception of alopecia or toxicities that are stable and well-controlled)
    • History of hypophysitis or pituitary dysfunction
    • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
    • Participants on prior DLL3-targeted therapy may be eligible if discussed with Amgen medical monitor prior to enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04702737
Other Study ID Numbers  ICMJE 20200040
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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 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. 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.
URL: http://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP