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A Phase 1b, Multicenter, Two-Part, Open label Study Of Trastuzumab Deruxtecan, An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti PD-1 Antibody, For Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC)
This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.
Study Objectives Primary Objectives - To determine the maximum tolerated dose/regimen (MTD) or the recommended dose for expansion (RDE) of DS-8201a when used in combination with pembrolizumab (Part 1) - To evaluate the efficacy of combination treatment with DS-8201a and pembrolizumab in human epidermal growth factor receptor-2 (HER2)-expressing locally advanced/metastatic breast cancer as well as HER2-expressing or HER2- mutant locally advanced/metastatic NSCLC (Part 2) Secondary Objectives - Key Secondary Objectives - To assess the safety and tolerability of the DS-8201a and pembrolizumab regimen - To determine the PK of DS-8201a when dosed in combination with pembrolizumab Other Secondary Objectives Not applicable. Exploratory Objectives - To analyze biomarkers related to the combination treatment - To understand the mechanism of response and resistance based on pretreatment, posttreatment, and on-treatment biopsies
DS-8201a (Trastuzumab Deruxtecan); Pembrolizumab (Keytruda); Trastuzumab Deruxtecan ()
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