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AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04885998
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of AMG 757 in combination with AMG 404.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: AMG 757 Drug: AMG 404 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Actual Study Start Date : September 27, 2021
Estimated Primary Completion Date : August 25, 2023
Estimated Study Completion Date : October 10, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Phase 1: Dose Exploration
The recommended phase 2 target dose (RP2D) of AMG 757 in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).
Drug: AMG 757
AMG 757 will be administered as an intravenous (IV) infusion.

Drug: AMG 404
AMG 404 will be administered as an intravenous (IV) infusion.

Experimental: Phase 2: Dose Expansion
Participants will receive the RP2D of AMG 757 in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.
Drug: AMG 757
AMG 757 will be administered as an intravenous (IV) infusion.

Drug: AMG 404
AMG 404 will be administered as an intravenous (IV) infusion.




Primary Outcome Measures :
  1. Number of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: 28 days ]
  2. Number of Participants with a Treatment-emergent Adverse Event (TEAE) [ Time Frame: 12 months ]
  3. Number of Participants with a Treatment-related Adverse Event [ Time Frame: 12 months ]
  4. Number of Participants with a Clinically Significant Change from Baseline in Vital Signs [ Time Frame: Baseline to Month 12 ]
  5. Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements [ Time Frame: Baseline to Month 12 ]
  6. Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests [ Time Frame: Baseline to Month 12 ]

Secondary Outcome Measures :
  1. Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: 12 months ]
  2. Duration of Response (DOR) [ Time Frame: 12 months ]
  3. Disease Control Rate (DCR) [ Time Frame: 12 months ]
  4. Progression-free Survival (PFS) [ Time Frame: 12 months ]
  5. Overall Survival (OS) [ Time Frame: 12 months ]
  6. Maximum Observed Concentration (Cmax) of AMG 757 in Combination with AMG 404 [ Time Frame: 12 months ]
  7. Minimum Observed Concentration (Cmin) of AMG 757 in Combination with AMG 404 [ Time Frame: 12 months ]
  8. Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 757 in Combination with AMG 404 [ Time Frame: 12 months ]


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:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
  • Age greater than or equal to 18 years old at the same time of signing the informed consent
  • Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1
  • 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
  • Major surgery within 28 days of first dose of AMG 757
  • Untreated or symptomatic brain metastases and leptomeningeal disease
  • Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti- cancer therapy and the first planned dose of AMG 757

Exceptions:

  • Participants who received prior chemotherapy must have completed at least 14 days before the first dose of AMG 757 and all treatment-related toxicity resolved to grade ≤ 1.
  • Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of AMG 757

    • Participants who received prior AMG 757 therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible
    • Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents
    • History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis
    • Participants with evidence of interstitial lung disease or active, non-infectious pneumonitis
    • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of AMG 757
    • History of solid organ transplantation
    • History of hypophysitis or pituitary dysfunction
    • Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted

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): NCT04885998


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

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Research Center Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Austria
Medizinische Universitaet Innsbruck Recruiting
Innsbruck, Austria, 6020
Universitaetsklinikum Allgemeines Krankenhaus Wien Recruiting
Wien, Austria, 1090
Belgium
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Universitair Ziekenhuis Leuven - Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04885998    
Other Study ID Numbers: 20200439
2020-005957-26 ( EudraCT Number )
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
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 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

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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:
Small Cell Lung Cancer
SCLC
Lung Cancer
AMG 757
AMG 404
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms