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NCT06054477 · ClinicalTrials.gov registry record · Phase 1
Study of ALE.C04 in Patients With Head and Neck Cancer
A Phase 1 study, sponsored by Alentis Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT06054477: Clinical Trial Phase 1 study, sponsored by Alentis Therapeutics.
NCT06054477 is a Phase 1 study that was terminated before completion, run by Alentis Therapeutics. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06054477, a Phase 1 study, was terminated before completion, sponsored by Alentis Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and to assess anti-tumor activity of ALE.C04 in combination with pembrolizumab in patients with Head and Neck Cancer.
Primary Outcome
Phase I dose escalation
Interventions
- DRUG Pembrolizumab
- DRUG ALE.C04
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-10-30 |
| Est. Completion | 2025-02-12 |
| Phase | Phase 1 |
Why NCT06054477 stopped before completion
NCT06054477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06054477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06054477 about?
NCT06054477 is a clinical study titled "Study of ALE.C04 in Patients With Head and Neck Cancer". The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and to assess anti-tumor activity of ALE.C04 i...
What is the current status of trial NCT06054477?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2023-10-30. Estimated completion is 2025-02-12.
What interventions are being tested in trial NCT06054477?
The interventions under investigation include: Pembrolizumab (DRUG), ALE.C04 (DRUG).
Who is sponsoring clinical trial NCT06054477?
This trial is sponsored by Alentis Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06054477's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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