A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumours

Description

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC).

Conditions

Advanced Solid Tumor, Metastatic Colorectal Carcinoma, Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma

Study Overview

Study Details

Study overview

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC).

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumours

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumours

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Irvine

Hoag Hospital, Irvine, California, United States, 92618

Stanford

Stanford Hospital and Clinics, Stanford, California, United States, 94305

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

St. Louis

Washington University in St. Louis, St. Louis, Missouri, United States, 63110

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Pittsburg

UPMC Hillman Cancer Center Research Pavilion, Pittsburg, Pennsylvania, United States, 15213

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Seattle

University of Washington/Fred Hutchinson Cancer Center, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Fusion Pharmaceuticals Inc.,

    Lorraine Hughes, MS, STUDY_DIRECTOR, Fusion Pharmaceuticals Inc.

    Study Record Dates

    2027-12-30