19
Participants
Start Date
February 7, 2023
Primary Completion Date
July 19, 2024
Study Completion Date
February 20, 2025
[225]-FPI-2059
"\[225Ac\]-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."
[111In]-FPI-2058
\[111In\]-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.
Westmead Hospital, Sydney
Advanced Molecular Imaging and Therapy, Glen Burnie
University of Alabama at Birmingham Hospital, Birmingham
University of Kentucky, Lexington
Washington University, St Louis
XCancer Omaha / Urology Cancer Center, Omaha
City of Hope Medical Center, Duarte
Hoag Family Cancer Institute, Newport Beach
Lead Sponsor
3B Pharmaceuticals GmbH
INDUSTRY