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A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), 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)

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Trial Profile

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), 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)

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 02 Apr 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Trastuzumab-deruxtecan (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; HER2 positive breast cancer; Non-small cell lung cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms TiP ENCORE
  • Sponsors Daiichi Sankyo Company; Daiichi Sankyo Inc

Most Recent Events

  • 24 Feb 2025 Planned primary completion date changed from 1 Dec 2024 to 1 Jul 2025.
  • 24 Feb 2025 Status changed from recruiting to active, no longer recruiting.
  • 02 Dec 2024 According to a Daiichi Sankyo Company media release, interim analyses of the breast cohorts from this study will be presented in a poster session on Friday, December 13, 12:30 - 2:00 pm at San Antonio Breast Cancer Symposium (#SABCS24).

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