EUCTR2020-001574-29-IT进行中（未招募）1 期
A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02) - DESTINY-PanTumor02
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
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
- •Locally advanced, unresectable, or metastatic disease based on most recent imaging.
- •The respective cohorts for patient inclusion are:
- •-Cohort 1: Biliary tract cancer
- •-Cohort 2: Bladder cancer
- •-Cohort 3: Cervical cancer
- •-Cohort 4: Endometrial cancer
- •-Cohort 5: Epithelial ovarian cancer
- •-Cohort 6: Pancreatic cancer
- •-Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.
- •Progressed following prior treatment or who have no satisfactory alternative treatment option.
- •Prior HER2 targeting therapy is permitted.
- •HER2 expression for eligibility may be based on local or central assessment.
- •Has measurable target disease assessed by the Investigator based on RECIST version 1.1.
- •Has protocol- defined adequate organ function including cardiac, renal and hepatic function.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •Uncontrolled intercurrent illness
- •History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
- •Lung-specific intercurrent clinically significant severe illnesses
- •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
- •Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
- •Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer.
研究者
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