A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

April 20, 2022

Primary Completion Date

September 8, 2023

Study Completion Date

September 8, 2023

Conditions
Advanced Solid TumorHead and Neck Squamous Cell CarcinomaBladder CarcinomaSusceptible FGFR3 Genetic AlterationsFGFR3FGFR3 OverexpressionFGFR3 ReceptorFGFR3 Protein OverexpressionOvarian CancerColorectal CancerBreast CancerLiver CancerLung CancerGastric Cancer
Interventions
DRUG

[225Ac]-FPI-1966

\[225Ac\]-FPI-1966 is a targeted alpha therapeutic that consists of vofatamab, a bifunctional chelate, and actinium-225, an alpha particle emitting radionuclide. In Phase 1, the dose depends on cohort assignment. In Phase 2, the RP2D regimen will be administered.

DRUG

[111In]-FPI-1967

\[111In\]-FPI-1967 is an imaging agent that consists of vofatamab, a bifunctional chelate and indium-111 radionuclide. Participants will receive \[111In\]-FPI-1967 Injection of 185 MBq for imaging.

BIOLOGICAL

vofatamab

Vofatamab is a Fibroblast Growth Factor Receptor 3 (FGFR3)-targeting human monoclonal antibody without a radioisotope. In Phase 1, the dose depends on cohort assignment. In Phase 2, if pre-dosing with vofatamab is indicated, the RP2D regimen will be administered.

Trial Locations (6)

6150

GC Murdoch, Murdoch

10065

Memorial Sloan Kettering Cancer Center, New York

52242

University of Iowa Hospitals and Clinics, Iowa City

91010

City of Hope, Duarte

94143

University of California, San Francisco, San Francisco

Unknown

St Vincent's Hospital, Melbourne

Sponsors
All Listed Sponsors
lead

Fusion Pharmaceuticals Inc.

INDUSTRY