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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)
Primary: 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 Secondary: For Indications A and B: -Characterize the pharmacokinetics of AMG 757 -Evaluate preliminary anti-tumor activity of AMG 757 Exploratory: 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"
AMG 757 (); Pembrolizumab (Keytruda)