FOG-001 in Locally Advanced or Metastatic Solid Tumors
Start Date
5/23/2023
Completion Date
8/31/2027
Summary
The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).
Detailed Description
This is a FIH, Phase 1/2, multicenter, open-label, non-randomized, dose escalation, dose expansion, and multiple subcutaneous dose study to evaluate the safety, tolerability, PK, pharmacodynamics, and antitumor activity of FOG-001 as monotherapy and in combination with other anticancer agents in participants with advanced or metastatic solid tumors likely or known to have a Wnt pathway activating mutation (WPAM), and FAP, a disorder of this pathway characterized by a germline mutation in the APC gene.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
FOG-001
mFOLFOX-6
Nivolumab
Trifluridine/tipiracil
Bevacizumab
FOG-001
Conditions
Locations
Mayo Clinic
Phoenix, Arizona 85054
United States
Honor Health
Scottsdale, Arizona 85258
United States
Arizona Cancer Center at University of Arizona
Tucson, Arizona 85719
United States
University of California, Los Angeles (UCLA)
Los Angeles, California 90095
United States
Stanford Cancer Institute, Stanford University
Palo Alto, California 94304
United States
University of California San Francisco, Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
Sarcoma Oncology Center
Santa Monica, California 90403
United States
University of Colorado
Aurora, Colorado 80045
United States
Yale University School of Medicine
New Haven, Connecticut 06520
United States
Johns Hopkins University, Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
United States
Mayo Clinic
Jacksonville, Florida 32224
United States
Florida Cancer Specialists
Lake Mary, Florida 32746
United States
Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke University
Durham, North Carolina 27705
United States
University Hospitals Cleveland Medical Center, Seidman Cancer Center
Cleveland, Ohio 44106
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United States
University of Pittsburgh Medical Center, Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee 37232
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
United States
University of Virginia
Charlottesville, Virginia 22908
United States
University of Wisconsin, Carbone Cancer Center
Madison, Wisconsin 53705
United States
Integrated Clinical Oncology Network (ICON)
South Brisbane, Queensland 4101
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia