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
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)
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)
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There are 37 Locations for this study
Duarte California, 91010, United States
New Haven Connecticut, 06510, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21287, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
New York New York, 10021, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Camperdown New South Wales, 2050, Australia
Graz , 8036, Austria
Salzburg , 5020, Austria
Villejuif , 94805, France
Wuerzburg , 97078, Germany
Shatin, New Territories , , Hong Kong
Kashiwa-shi Chiba, 277-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Wakayama-shi Wakayama, 641-8, Japan
Amsterdam , 1066 , Netherlands
Maastricht , 6229 , Netherlands
Jozefow , 05-41, Poland
Otwock , 05-40, Poland
Barcelona Cataluña, 08035, Spain
Barcelona Cataluña, 08036, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Lausanne , 1011, Switzerland
Sankt Gallen , 9007, Switzerland
Kaohsiung , 80756, Taiwan
Taipei , 11490, Taiwan
Taoyuan , 33305, Taiwan
Manchester , M20 4, United Kingdom
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