Sponsor reprioritization of active trials.
A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours
Sponsor study identifier
interventional
19
2 countries
8
Study Start
February 7, 2023
Actual (reported)Primary Completion
July 19, 2024
Actual (reported)Study Completion
February 20, 2025
Actual (reported)This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of \[225Ac\]-FPI-2059 and \[111In\]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 20, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2022
Actual (reported)November 4, 2022
Actual (reported)February 7, 2023
Actual (reported)July 19, 2024
Actual (reported)February 20, 2025
Actual (reported)Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058
approximately 5 years post final administration
Maximum tolerated dose (MTD) of [225Ac]-FPI-2059
56 days post administration
Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest
within 56 days of administration
\[225Ac\]-FPI-2059 is a targeted alpha therapeutic that consists of an NTSR1-targeting small molecule that is linked to Ac-225, an alpha particle emitting radionuclide. Participants will be dosed through IV administration every 56 days up to four cycles. The dose depends on cohort assignment. In the Dose Expansion arm, \[225Ac\]-FPI-2059 will be administered at the RP2D as determined in Phase 1 Dose Escalation.
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Hoag Family Cancer Institute
Newport Beach, California, 92663, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Advanced Molecular Imaging and Therapy
Glen Burnie, Maryland, 21061, United States
Washington University
St Louis, Missouri, 63110, United States
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 68130, United States
Aaron Enke
3B Pharmaceuticals GmbH
19 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2022
First Posted
November 4, 2022
Study Start
February 7, 2023
Actual (reported)Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1
approximately 5 years post final administration
Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images
within 56 days of administration
Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-life
approximately 36 days of final administration
\[111In\]-FPI-2058 is an imaging agent that consists of an NTSR1-targeting small molecule linked to In-111.Participants will receive \[111In\]-FPI-2058 by IV Injection for imaging once during screening period. The dose is consistent across cohorts.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Primary Completion
July 19, 2024
Actual (reported)Study Completion
February 20, 2025
Actual (reported)Last Updated
August 24, 2025
Record last verified: 2025-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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