Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

This is an interventional treatment trial for Small Cell Lung Carcinoma focused on measuring Half-Life Extended (HLE) Bispecific T cell engager (BiTE®), Delta-like protein 3 (DLL3), Tarlatamab, Oncology, Immunology Read More

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)