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

PHASE1TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

February 7, 2023

Primary Completion Date

July 19, 2024

Study Completion Date

February 20, 2025

Conditions
Pancreatic Ductal Adenocarcinoma (PDAC)Squamous Cell Carcinoma of Head and NeckColorectal CancerGastric CancerEwing SarcomaNTSR1 Expressing Solid TumoursNeuroendocrine Differentiated (NED) Prostate Cancer
Interventions
DRUG

[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."

DRUG

[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.

Trial Locations (8)

2145

Westmead Hospital, Sydney

21061

Advanced Molecular Imaging and Therapy, Glen Burnie

35249

University of Alabama at Birmingham Hospital, Birmingham

40536

University of Kentucky, Lexington

63110

Washington University, St Louis

68130

XCancer Omaha / Urology Cancer Center, Omaha

91010

City of Hope Medical Center, Duarte

92663

Hoag Family Cancer Institute, Newport Beach

Sponsors
All Listed Sponsors
lead

3B Pharmaceuticals GmbH

INDUSTRY