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NCT04699630 · ClinicalTrials.gov registry record · Phase 2

A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer

A Phase 2 study, sponsored by SCRI Development Innovations.

Completed
Registry status
Phase 2
Development phase
121
Enrollment target

NCT04699630: Completed Phase 2 study, sponsored by SCRI Development Innovations.

NCT04699630 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 121 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04699630, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.

COMPLETED
Registry status
Phase 2
Development phase
121 participants
Enrollment target

Study Summary

This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).

Primary Outcome

Overall Response Rate (ORR) is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) out of all treated participants. Confirmed response is two consecutive CR or PR at least 4 weeks apart according to RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of lesion diameters.

Interventions

  • DRUG U3-1402

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2021-05-03
Est. Completion 2025-04-09
Phase Phase 2
SCRI Development Innovations

146 total trials

What the finished NCT04699630 record still lists

NCT04699630 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which U3-1402 is the first listed.

NCT04699630 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04699630 about?

NCT04699630 is a clinical study titled "A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer". This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).

What is the current status of trial NCT04699630?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2021-05-03. Estimated completion is 2025-04-09.

What interventions are being tested in trial NCT04699630?

The interventions under investigation include: U3-1402 (DRUG).

Who is sponsoring clinical trial NCT04699630?

This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04699630's enrollment target sits among peer trials

121 567th of 2000 higher than 1,432 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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Source: ClinicalTrials.gov NCT04699630, the US trial registry maintained by the National Library of Medicine. NCT04699630 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.