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Clinical Trial Summary

This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast
  • Neoplasms

NCT number NCT04639219
Study type Interventional
Source AstraZeneca
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 30, 2020
Completion date July 14, 2026