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

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: NCT03319940
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : February 13, 2020
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 Drug: Pembrolizumab Phase 1

Detailed Description:
This is an open-label, ascending, multiple dose, phase 1 study evaluating AMG 757 monotherapy and in combination with anti-PD1 therapy. AMG 757 will be 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
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open-label, ascending, multiple dose, phase 1 study evaluating AMG 757 monotherapy and in combination with anti-PD1 therapy in subjects with Small Cell Lung Cancer. The dose exploration phases of the study will estimate the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of AMG 757 either as monotherapy or in combination with pembrolizumab. This will be followed by dose expansion phase to confirm RP2D and to obtain further safety and efficacy 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 : August 7, 2022
Estimated Study Completion Date : August 4, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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

Experimental: Part C
AMG 757 with Pembrolizumab
Drug: AMG 757
AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Drug: Pembrolizumab
Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2




Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities (DLT) for all indications [ Time Frame: 12 months ]
  2. Number of participants with treatment-emergent adverse events (AEs) for all indications [ Time Frame: 12 months ]
  3. Number of participants with treatment-related AEs for all indications [ Time Frame: 12 months ]
  4. Number of participants with clinically significant changes in vital signs for all indications [ Time Frame: 12 months ]
  5. Number of participants with significant changes in ECG for all indications [ Time Frame: 12 months ]
  6. Number of participants with significant changes in physical examinations for all indications [ Time Frame: 12 months ]
  7. Number of participants with significant changes in clinical laboratory tests for all indications [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Maximum observed concentration (Cmax) following intravenous administration for all indications [ Time Frame: 12 months ]
  2. Minimum observed concentration (Cmin) following intravenous administration for all indications [ Time Frame: 12 months ]
  3. Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications [ Time Frame: 12 months ]
  4. Accumulation following multiple dosing for all indications [ Time Frame: 12 months ]
  5. Half-life (t1/2) following intravenous administration for all indications [ Time Frame: 12 months ]
  6. Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for all indications [ Time Frame: 12 months ]
  7. Duration of Response (DOR) for all indications [ Time Frame: 12 months ]
  8. 9-month Progression-Free Survival (PFS) for all indications [ Time Frame: 9 months ]
  9. 9-month Overall Survival (OS) for all indications [ Time Frame: 9 months ]
  10. Relapse Free Survival (RFS) for subjects with ED SCLC with ongoing clinical benefit following no more than 6 cycles of platinum-based chemotherapy in monotherapy arm only [ 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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures
  • Age greater than or equal to 18 years old at the time of signing the informed consent
  • Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC):
  • Part A and Part C: RR SCLC who progressed or recurred following platinum-based regimen;
  • 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 than or equal to 28 days prior to the study day 1 (first-line consolidation setting)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Subjects 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 prior to first dose of AMG 757 with exceptions
  • Major surgery within 28 days of first dose AMG 757
  • Untreated or symptomatic brain metastases and leptomeningeal disease
  • 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 less than or equal to 1
  • Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757
  • Subjects who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-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
  • Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years

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, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110-1093
United States, New York
Research Site Recruiting
New York, New York, United States, 10017
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    
Other Study ID Numbers: 20160323
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
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: 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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Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents