A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
2期
进行中（已停止招募）
NCT04639219
| 适应症 | Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast |
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| 分期 | 2期 |
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| 申办方 | AstraZeneca |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 102 人 |
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| 干预（药物） | Trastuzumab deruxtecan |
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| 开始日期 | 2020年12月30日 |
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| 完成日期 | 2023年1月25日 |
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| 结果公布日 | 2024年2月15日 |
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摘要
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.
Confirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR)
Tumor scans performed at screening,then every 6 weeks (q6w) +/- 1 week relative to date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) · percentage of participants
| T-DXd | 29.4 percentage of participants |
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