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

Inoguchi Akihiro0 个研究点目标入组 100 人开始时间: 2021年6月4日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

•- 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.

发起方

Inoguchi Akihiro