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NCT04446260 · ClinicalTrials.gov registry record · Phase 1
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
A Phase 1 study, sponsored by Jiangsu HengRui Medicine Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 396
- Enrollment target
NCT04446260: Completed Phase 1 study, sponsored by Jiangsu HengRui Medicine Co..
NCT04446260 is a Phase 1 study that has completed, run by Jiangsu HengRui Medicine Co.. The registered enrollment target is 396 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (560% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04446260, a Phase 1 study, has completed, sponsored by Jiangsu HengRui Medicine Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 396 participants
- Enrollment target
Study Summary
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Primary Outcome
Frequency and seriousness of treatment emergent adverse events (TEAEs)
Interventions
- DRUG SHR-A1811
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2020-09-07 |
| Est. Completion | 2025-06-04 |
| Phase | Phase 1 |
What the finished NCT04446260 record still lists
NCT04446260 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (560% higher).
The record links to 0 conditions, and to 1 intervention - of which SHR-A1811 is the first listed.
NCT04446260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04446260 about?
NCT04446260 is a clinical study titled "A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors". This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
What is the current status of trial NCT04446260?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 396 participants. The study started on 2020-09-07. Estimated completion is 2025-06-04.
What interventions are being tested in trial NCT04446260?
The interventions under investigation include: SHR-A1811 (DRUG).
Who is sponsoring clinical trial NCT04446260?
This trial is sponsored by Jiangsu HengRui Medicine Co., which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04446260's enrollment target sits among peer trials
396 77th of 2000 higher than 1,924 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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