A Phase 1 Study of [225Ac]-FPI-1434 Injection
Public ClinicalTrials.gov record NCT03746431. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Study of [225Ac]-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03746431
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 78 participants
Conditions and interventions
Conditions
Interventions
- [111In]-FPI-1547 Injection Drug
- [225Ac]-FPI-1434 Injection multi-dose Drug
- FPI-1175 Infusion Biological
- [225Ac]-FPI-1434 Injection single-dose Drug
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 16, 2019
- Primary completion
- Dec 2, 2025
- Completion
- Dec 2, 2025
- Last update posted
- Jan 6, 2026
2019 – 2025
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14203 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03746431, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 6, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03746431 live on ClinicalTrials.gov.