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Study Evaluating Safety, Tolerability and PK of AMG 757 in Adults With Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03319940
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
A study to assess the safety, tolerability, and pharmacokinetics of AMG 757 in Subjects with Small Cell Lung Cancer

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

Detailed Description:
This is an open-label, ascending, multiple dose, phase 1 study evaluating AMG 757 administered as a short term intravenous (IV) infusion in subjects with small cell lung cancer. AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open-label, ascending, multiple dose, phase 1 study evaluating AMG 757 in subjects with Small Cell Lung Cancer. The dose exploration phase of the study will estimate the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of AMG 757. This will be followed by dose expansion phase to confirm the MTD and to obtain further safety and efficacy data. Alternative dosing schedule(s) may be explored based on emerging pharmacokinetic and safety data
Masking: None (Open Label)
Masking Description: The patient, investigator, investigative staff, medical monitor and care provider will not be masked for the study.
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer
Actual Study Start Date : December 26, 2017
Estimated Primary Completion Date : July 18, 2021
Estimated Study Completion Date : July 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: AMG 757 Treatment Drug: AMG 757
AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)




Primary Outcome Measures :
  1. Subject incidence of dose limiting toxicity [ Time Frame: 3 years ]
    Number of subjects who experience dose limiting toxicities

  2. Subject incidence of treatment-emergent and treatment-related adverse events [ Time Frame: 3 years ]
    Number of subjects who experience treatment-emergent and treatment-related adverse events



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 18 years old at the time of signing the informed consent
  • Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC):

    • Part A: RR SCLC who progressed or recurred following platinum-based chemotherapy; Note: Subjects with a diagnosis of combined small cell carcinoma with >50% small cells may be considered for inclusion in the dose escalation phase of part A based on investigator discretion and after discussion with the medical monitor
    • Part B: ED SCLC with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following no more than 6 cycles of first-line platinum-based chemotherapy with the last dose of chemotherapy greater then equal to 28 days prior to the study day 1 (first-line consolidation setting)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Minimum life expectancy of 12 weeks
  • Indication A only: at least 2 measurable lesions as defined per modified RECIST 1.1 within 28 days prior to the first dose of AMG 757
  • Subjects with treated brain metastases are eligible provided they meet the following criteria:

    • Definitive therapy was completed at least 2 weeks prior to the first dose of AMG 757.
    • There is no evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudo progression can be demonstrated by appropriate means and after discussion with the medical monitor.
    • Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.

Exclusion Criteria:

  • History of other malignancy within the past 2 years prior to first dose of AMG 757 except:

    • Malignancy (other than in situ) treated with curative intent and with no known active disease present for 2 years before first dose of AMG 757 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 in situ cancer without evidence of disease.
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer
    • Adequately treated urothelial papillary noninvasive carcinoma
  • Major surgery within 28 days of first dose AMG 757
  • Untreated or symptomatic brain metastases and leptomeningeal disease
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 757
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 757
  • Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose AMG 757
  • Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of AMG 757

Exceptions:

  • Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade .1
  • Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757
  • Subjects who experienced immune related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immuno-oncology agents
  • Has 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
  • Live vaccination is not allowed for at least 4 weeks prior to the start of AMG 757 treatment, during treatment, and until end of last study dose

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): NCT03319940


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, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60637
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110-1093
United States, Ohio
Research Site Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37203
Australia, New South Wales
Research Site Recruiting
Camperdown, New South Wales, Australia, 2050
France
Research Site Recruiting
Villejuif, France, 94805
Germany
Research Site Recruiting
Wurzburg, Germany, 97080
Japan
Research Site Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Netherlands
Research Site Recruiting
Amsterdam, Netherlands, 1066 CX
Spain
Research Site Recruiting
Madrid, Spain, 28041
United Kingdom
Research Site Recruiting
Manchester, United Kingdom, M20 4BX
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: NCT03319940     History of Changes
Other Study ID Numbers: 20160323
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 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 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 link 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:
Half Life Extended (HLE) Bispecific T cell engager (BiTE®)
Delta-like protein 3 (DLL3)

Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases