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NCT04639219 · ClinicalTrials.gov registry record · Phase 2
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
A Phase 2 study of Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
- 20
- Study locations
NCT04639219: Active Phase 2 study of Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast, sponsored by AstraZeneca.
NCT04639219 is a Phase 2 study of Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04639219, a Phase 2 study of Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Confirmed ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR), as determined by ICR per RECIST v1.1. A CR was defined as disappearance of all target lesions (TLs) and PR was defined as at least a 30% decrease in the sum of the diameters (dms) of TL, taking as reference the baseline sum of diameters as long as criteria for PD were not met. An ICR of all radiological imaging data was carried out using RECIST v1.1. All images were co
Conditions Studied
Interventions
- DRUG Trastuzumab deruxtecan
Study Locations (20)
Other
- Research Site - Anderlecht
- Research Site - Copenhagen
- Research Site - Bordeaux
- Research Site - Lyon
- Research Site - Villejuif
- Research Site - Milan
- Research Site - Milan
- Research Site - Naples
- Research Site - Chūōku
New York
- Research Site - Commack
- Research Site - Harrison
- Research Site - New York
Massachusetts
- Research Site - Boston
- Research Site - Boston
California
- Research Site - Santa Rosa
Indiana
- Research Site - Muncie
New Jersey
- Research Site - Middletown
Texas
- Research Site - Houston
Virginia
- Research Site - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2026-07-14 |
| Phase | Phase 2 |
What the registry record for NCT04639219 still lists
NCT04639219 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 1 condition, with Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast appearing as the primary indexed condition, and to 1 intervention - of which Trastuzumab deruxtecan is the first listed.
NCT04639219 names 20 study sites across 9 states, led by Other, New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04639219 about?
NCT04639219 is a clinical study titled "A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations". 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 progre...
What is the current status of trial NCT04639219?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2020-12-30. Estimated completion is 2026-07-14.
What conditions does trial NCT04639219 study?
This clinical trial studies the following conditions: Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast.
What interventions are being tested in trial NCT04639219?
The interventions under investigation include: Trastuzumab deruxtecan (DRUG).
Who is sponsoring clinical trial NCT04639219?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04639219 being conducted?
This trial has 20 study locations across California, Indiana, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04639219's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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