EUCTR2020-002368-30-DK进行中（未招募）1 期
A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology - DESTINY-PanTumor01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adults =18 years old. Other age restrictions may apply as per local regulations.
- •Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS, who have progressed following prior treatment or who have no satisfactory alternative treatment options.
- •Prior HER2 targeted therapy is permitted.
- •All patients must provide an FFPE tumor sample for retrospective central HER2 testing.
- •LVEF =50%
- •ECOG 0-1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
- •HER2 mutant NSCLC.
- •History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
- •Lung-specific intercurrent clinically significant severe illnesses.
- •History of active primary immunodeficiency, known HIV, active HBV or HCV infection
- •Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
- •Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
- •Has spinal cord compression or clinically active central nervous system metastases.
研究者
相似试验
进行中（未招募）
1 期
A study to investigate anti-tumor activity and safety of trastuzumab deruxtecan in patients with solid tumors carrying specific HER2 mutations.Treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology.EUCTR2020-002368-30-FRAstraZeneca AB100
招募中
2 期
A clinical trial to evaluate the efficacy and safety of Trastuzumab Deruxtecan in treating patients with HER2 positive Solid TumorsCTRI/2021/03/031930AstraZeneca AB
进行中（未招募）
1 期
A study to investigate anti-tumor activity and safety of trastuzumab deruxtecan in patients with solid tumors carrying specific HER2 mutations.Treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology.MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002368-30-ITASTRAZENECA AB100
招募中
1 期
The study of Trastuzumab Deruxtecan to assess its efficacy, safety and tolerability in Patients with Selected HER2 Expressing TumorsHER2 Expressing TumorsMedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2CTIS2023-504721-39-02AstraZeneca AB413
进行中（未招募）
2 期
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating MutationsAdvanced Solid Tumors With HER2JPRN-jRCT2031210132Inoguchi Akihiro100