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HER2活性化変異を有する固形腫瘍の治療におけるT-DXdの研究

基本情報

NCT ID
NCT04639219
ステータス
実施中(募集終了)
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
102
治験依頼者名
AstraZeneca

概要

This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.

対象疾患

Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast

介入

Trastuzumab deruxtecan(DRUG)

依頼者(Sponsor)