A Phase 1 Study Evaluating 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)
For adult subjects with RR SCLC who progressed or recurred following platinum-based chemotherapy (Indication A) and ED SCLC with ongoing clinical benefit following no more than 6 cycles of platinum-based chemotherapy (Indication B):
-Evaluate the safety and tolerability of AMG 757
-Determine the MTD or TP2D of AMG 757
For Indications A and B:
-Characterize the pharmacokinetics of AMG 757
-Evaluate preliminary anti-tumor activity of AMG 757
For Indications A and B:
-Evaluate immunogenicity of AMG 757
-Evaluate protein, nucleic acid and cellular biomarkers in blood pre- and post AMG 757 treatment (eg cytokines, lymphocyte status, CTCs, sDLL3)
-Evaluate relationship of baseline target protein expression in tumor tissue, tumor microenvironment characteristics and clinical benefit
For Indication B only:
-Evaluate the effects of chemotherapy and time elapsed post chemotherapy on "T cell fitness"
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
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
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
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