A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations - DPT01
Study identifier:D967MC00001
ClinicalTrials.gov identifier:NCT04639219
EudraCT identifier:2020-002368-30
CTIS identifier:N/A
Recruitment Complete
Official Title
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
Medical condition
Advanced solid tumors with HER2 mutation,eg:colorectal,urothelial,gastric, hepatobiliary,endometrial,melanoma,ovarian,cervical,salivary gland,pancreatic,breast
Phase
Phase 2
Healthy volunteers
No
Study drug
Trastuzumab deruxtecan
Sex
All
Actual Enrollment
102
Study type
Interventional
Age
18 Years - 120 Years
Date
Study Start Date: 30 Dec 2020
Primary Completion Date: 25 Jan 2023
Estimated Study Completion Date: 14 Jul 2026
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Daiichi Sankyo Co., Ltd.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: T-DXd T-DXd monotherapy | - |
Contacts
Contact
AstraZeneca Clinical Study Information Center
