A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours

Stopped early · Phase 1

Conditions studied: Pancreatic Ductal Adenocarcinoma (PDAC), Squamous Cell Carcinoma of Head and Neck, Colorectal Cancer, Gastric Cancer, Ewing Sarcoma, NTSR1 Expressing Solid Tumours, Neuroendocrine Differentiated (NED) Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05605522

Run by

3B Pharmaceuticals GmbH

People needed

19

Starts

2023-02-07

Expected to finish

2025-02-20

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States
• City of Hope Medical Center — Duarte, California, United States
• Hoag Family Cancer Institute — Newport Beach, California, United States
• University of Kentucky — Lexington, Kentucky, United States
• Advanced Molecular Imaging and Therapy — Glen Burnie, Maryland, United States
• Washington University — St Louis, Missouri, United States
• XCancer Omaha / Urology Cancer Center — Omaha, Nebraska, United States
• Westmead Hospital — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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