Spots Global Cancer Trial Database for A Phase 1/2 Study of [225Ac]-FPI-1434 Injection
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Trial Identification
Brief Title: A Phase 1/2 Study of [225Ac]-FPI-1434 Injection
Official Title: A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours
Study ID: NCT03746431
Study Description
Brief Summary: This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of \[225Ac\]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent), and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of repeat doses of \[225Ac\]-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent).
Detailed Description: This study consists of a Phase 1 portion and a Phase 2 portion. Phase 1 includes the following cohorts: Single dose-ascending cohorts and Multi- dose ascending cohorts of \[225Ac\]-FPI-1434 and Multi- dose ascending cohorts evaluating administration of FPI-1175 (cold antibody), followed by, \[225Ac\]-FPI-1434 (cold + hot), with cycles repeating every 42 days. And Cold Antibody Sub-study evaluating administration of ascending doses of FPI-1175 followed by \[111In\]-FPI-1547. The Phase 2 will evaluate \[111In\]-FPI-1547 and \[225Ac\]-FPI-1434 with or without FPI-1175 in tumour-specific cohorts. The decision to utilize FPI-1175 in the Phase 2 portion of the study will be determined based on Phase 1 data, including safety, tolerability, pharmacokinetic and dosimetry results.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Juravinski Cancer Center - Hamilton Health, Hamilton, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre Hospitalier De I'Universite de Montreal, Montréal, Quebec, Canada
Quebec University Hospital- Laval, Québec City, Quebec, Canada
Contact Details
Name: Julia Kazakin, MD
Affiliation: Fusion Pharmaceuticals Inc.
Role: STUDY_DIRECTOR
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