Study Title

A Phase 1/2 Study of [225Ac]-FPI-1434 Injection

Study Details

Description:

This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical trial designed to investigate safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumour activity of [111In]-FPI-1547 Injection (radioimmuno-imaging agent) and [225Ac]-FPI-1434 Injection (radioimmuno-therapeutic) 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. The study consists of a Phase 1 portion that includes dose ascending cohorts (single and multi-dosing administration with/without cold antibody), a Cold Antibody Sub-Study, and a Phase 2 portion that includes tumour-specific cohorts.

Sponsor:

Fusion Pharmaceuticals, Inc.

Contacts:

Julia Kazakin (Medical Monitor)

clinicaltrials@fusionpharma.com

(888) 506-4215

Government Study Link:

NCT03746431 - Click here to see study on

ClinicalTrials.gov

Inclusion

Measurable or evaluable disease in accordance with RECIST 1.1.
Life expectancy of greater than 3 months as judged by the treating physician
Pathologically documented, definitively diagnosed, advanced solid tumour
Available tumour tissue (either archival or fresh biopsy) for IGF-1R immunohistochemistry.
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1

Exclusion

Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment into this study.
Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception of residual grade 2 alopecia.
Contraindications to or inability to perform the required imaging procedures in this study
Prior organ transplantation, including stem cell transplantation.

Patient Education

Patient Education Not Yet Provided

Publications

Dose-Escalation Study Of [225Ac]-FPI-1434 In Patients With IGF-1R-Expressing Advanced Solid Tumors: Preliminary Pharmacology And Dosimetry Results

Locations

United States

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104, United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215, United States