Lung Cancer Clinical Trial

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

Summary

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

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Full Description

This is an open-label, ascending, multiple dose, phase 1 study evaluating AMG 757 monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. 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)

View Eligibility Criteria

Eligibility 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, C, D, E, F, and G: RR SCLC who progressed or recurred following platinum-based regimen;
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 (includes new lesions or progression in previously treated lesions) 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
No evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If history of SARS-CoV-2, no acute symptoms of coronavirus disease 2019 (COVID-19) within14 days prior to first dose of investigational product (counted from day of positive test for asymptomatic subjects)

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

382

Study ID:

NCT03319940

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 35 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
Yale New Haven Hospital
New Haven Connecticut, 06510, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Winship Cancer Institute
Atlanta Georgia, 30322, United States
University of Chicago
Chicago Illinois, 60637, United States
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21287, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Washington University
Saint Louis Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Columbus Ohio, 43210, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Chris OBrien Lifehouse
Camperdown New South Wales, 2050, Australia
Medizinische Universitaet Graz
Graz , 8036, Austria
Universitaetsklinikum Salzburg
Salzburg , 5020, Austria
Gustave Roussy
Villejuif , 94805, France
Universitätsklinikum Würzburg
Würzburg , 97078, Germany
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
Wakayama Medical University Hospital
Wakayama-shi Wakayama, 641-8, Japan
Nederlands Kanker Instituut, Antoni van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht , 6229 , Netherlands
Biokinetica SA
Jozefow , 05-41, Poland
Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina
Otwock , 05-40, Poland
Hospital Universitari Vall d Hebron
Barcelona Cataluña, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona Cataluña, 08036, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Centre Hospitalier Universitaire Vaudois
Lausanne , 1011, Switzerland
Kantonsspital St Gallen
Sankt Gallen , 9007, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 80756, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan , 33305, Taiwan
Christie Hospital
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

382

Study ID:

NCT03319940

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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