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NCT04319757 · ClinicalTrials.gov registry record · Phase 1
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
A Phase 1 study, sponsored by Acepodia Biotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04319757: Completed Phase 1 study, sponsored by Acepodia Biotech.
NCT04319757 is a Phase 1 study that has completed, run by Acepodia Biotech. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04319757, a Phase 1 study, has completed, sponsored by Acepodia Biotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.
Primary Outcome
Number of subjects experiencing adverse events, and the frequency and severity of adverse events. Endpoint for determining the Maximum Tolerated Dose (MTD). If MTD is not identified, the highest dose administered becomes the Maximum Administered Dose (MAD).
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG ACE1702
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2024-07-15 |
| Phase | Phase 1 |
What the finished NCT04319757 record still lists
NCT04319757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT04319757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04319757 about?
NCT04319757 is a clinical study titled "ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors". ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with adv...
What is the current status of trial NCT04319757?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-06-24. Estimated completion is 2024-07-15.
What interventions are being tested in trial NCT04319757?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), ACE1702 (DRUG).
Who is sponsoring clinical trial NCT04319757?
This trial is sponsored by Acepodia Biotech, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04319757's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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