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Brief Title: FOG-001 in Locally Advanced or Metastatic Solid Tumors
Official Title: A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors
Study ID: NCT05919264
Brief Summary: The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.
Detailed Description: This first-in-human, Phase 1/2, multicenter, open-label, non-randomized dose escalation and expansion study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of FOG-001 in participants with locally advanced or metastatic solid tumors. FOG-001 is a first-in-class direct inhibitor of Beta-catenin, which functions by blocking its interaction with the T-cell factor (TCF) family of transcription factors.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Honor Health, Scottsdale, Arizona, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Oregon Health and Science University, Portland, Oregon, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
Name: Keith Orford, MD, PhD
Affiliation: Fog Pharmaceuticals, Inc.
Role: STUDY_CHAIR