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NCT04479436 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Daiichi Sankyo.
- Terminated
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT04479436: Clinical Trial Phase 2 study, sponsored by Daiichi Sankyo.
NCT04479436 is a Phase 2 study that was terminated before completion, run by Daiichi Sankyo. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04479436, a Phase 2 study, was terminated before completion, sponsored by Daiichi Sankyo.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor expression level in otherwise refractory tumors.
Primary Outcome
ORR defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) as assessed by blinded independent central review. CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesion based on RECIST v1.1.
Interventions
- DRUG Patritumab Deruxtecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 2 |
Why NCT04479436 stopped before completion
NCT04479436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Patritumab Deruxtecan is the first listed.
NCT04479436 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04479436 about?
NCT04479436 is a clinical study titled "A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer". This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor...
What is the current status of trial NCT04479436?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-09-14. Estimated completion is 2022-02-03.
What interventions are being tested in trial NCT04479436?
The interventions under investigation include: Patritumab Deruxtecan (DRUG).
Who is sponsoring clinical trial NCT04479436?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04479436's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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