CTIS2023-504721-39-02招募中1 期
A Phase II, 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) - D967VC00001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 413
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 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.
排除标准
- •History of non-infectious pneumonitis/ILD that required steroids, 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 gastroesophageal junction, or non-small cell lung cancer, Medical conditions that may interfere with the subject's participation in the study.
研究者
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