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

AstraZeneca AB0 个研究点目标入组 100 人开始时间: 2021年3月24日最近更新: 2024年9月2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
•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

•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