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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 is a Phase 1 study that was terminated before completion, run by Fusion Pharmaceuticals. The registered enrollment target is 78 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03746431
The ClinicalTrials.gov registry entry for NCT03746431 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fusion Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which [111In]-FPI-1547 Injection is the first listed.
NCT03746431 reports 0 study locations.
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.
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