A Phase 1 Study of [225Ac]-FPI-1434 Injection

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

253

Participants

Timeline

Start Date

January 17, 2019

Primary Completion Date

April 30, 2026

Study Completion Date

June 30, 2026

Conditions
Advanced Solid TumoursEndometrial CancerCervical CancerOvarian CancerBreast CancerTriple Negative Breast Cancer (TNBC)HER2-negative Breast CancerHead and Neck Squamous Cell Carcinoma (HNSCC)Adrenocortical CarcinomaUveal Melanoma
Interventions
DRUG

[111In]-FPI-1547 Injection

\[111In\]-FPI-1547 is a targeted radioimmuno-imaging agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Indium-111, a radionuclide. Patients will receive \[111In\]-FPI-1547 Injection of 185 MBq (5 mCi) for imaging.

DRUG

[225Ac]-FPI-1434 Injection multi-dose

\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive multiple doses of \[225Ac\]-FPI-1434 Injection. Dose is per cohort assignment.

BIOLOGICAL

FPI-1175 Infusion

FPI-1175 is an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody without a radioisotope. Patients will receive FPI-1175 Infusion at a dose per cohort assignment.

DRUG

[225Ac]-FPI-1434 Injection single-dose

\[225Ac\]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive a single dose of \[225\]-FPI-1434 Injection. Dose is per cohort assignment.

Trial Locations (13)

3084

RECRUITING

Austin Hospital, Heidelberg

5000

COMPLETED

Royal Adelaide Hospital, Adelaide

10065

COMPLETED

Memorial Sloan Kettering Cancer Center, New York

14203

COMPLETED

Roswell Park Comprehensive Cancer Center, Buffalo

19104

COMPLETED

Hospital of the University of Pennsylvania, Philadelphia

55455

RECRUITING

Masonic Cancer Center, University of Minnesota, Minneapolis

77030

COMPLETED

University of Texas MD Anderson Cancer Center, Houston

91010

COMPLETED

City of Hope, Duarte

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

L8V 5C2

COMPLETED

Juravinski Cancer Center - Hamilton Health, Hamilton

M5G 2C1

COMPLETED

Princess Margaret Cancer Centre, Toronto

H2X 0C1

RECRUITING

Centre Hospitalier De I'Universite de Montreal, Montreal

G1R 2J6

COMPLETED

Quebec University Hospital- Laval, Québec

Sponsors
All Listed Sponsors
lead

Fusion Pharmaceuticals Inc.

INDUSTRY