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NCT03746431 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of [225Ac]-FPI-1434 Injection
A Phase 1 study, sponsored by Fusion Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
NCT03746431: Clinical Trial Phase 1 study, sponsored by Fusion Pharmaceuticals.
NCT03746431 is a Phase 1 study that was terminated before completion, run by Fusion Pharmaceuticals. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03746431, a Phase 1 study, was terminated before completion, sponsored by Fusion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of \[225Ac\]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent), and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of repeat doses of \[225Ac\]-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent).
Primary Outcome
Phase 1
Interventions
- DRUG [111In]-FPI-1547 Injection
- DRUG [225Ac]-FPI-1434 Injection multi-dose
- BIOLOGICAL FPI-1175 Infusion
- DRUG [225Ac]-FPI-1434 Injection single-dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2025-12-03 |
| Phase | Phase 1 |
Why NCT03746431 stopped before completion
NCT03746431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 4 interventions - of which [111In]-FPI-1547 Injection is the first listed.
NCT03746431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03746431 about?
NCT03746431 is a clinical study titled "A Phase 1 Study of [225Ac]-FPI-1434 Injection". This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of \[225Ac\]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of \[111In\]...
What is the current status of trial NCT03746431?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2019-01-17. Estimated completion is 2025-12-03.
What interventions are being tested in trial NCT03746431?
The interventions under investigation include: [111In]-FPI-1547 Injection (DRUG), [225Ac]-FPI-1434 Injection multi-dose (DRUG), FPI-1175 Infusion (BIOLOGICAL), [225Ac]-FPI-1434 Injection single-dose (DRUG).
Who is sponsoring clinical trial NCT03746431?
This trial is sponsored by Fusion Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03746431's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 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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