Study Evaluating Safety, Tolerability and PK of AMG 757 in Adults With Small Cell Lung Cancer
- Interventional
- Recruiting
- NCT03319940
Contact Information
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer
A study to assess the safety, tolerability, and pharmacokinetics of AMG 757 in Subjects with Small Cell Lung Cancer
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)
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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)
- 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)