FOG-001 in Locally Advanced or Metastatic Solid Tumors (NCT05919264)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
2. Adequate organ and marrow function. Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g):
3. Diagnosis of treatment-refractory advanced/metastatic solid tumor that is non-MSI-H or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT- pathway activating mutations (WPAMs). Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):
4. Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
5. At least one lesion that is suitable for a core needle biopsy. Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):
6. Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1 Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):
7. Desmoid tumor (aggressive fibromatosis) Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:
8. Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC
9. Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.
10. One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed. Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab
11. Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.
12. MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1/PD-L1

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (33 Sites)

• Mayo Clinic — Phoenix, Arizona
• Honor Health — Scottsdale, Arizona
• Arizona Cancer Center at University of Arizona — Tucson, Arizona
• University of California, Los Angeles (UCLA) — Los Angeles, California
• Stanford Cancer Institute, Stanford University — Palo Alto, California
• University of California San Francisco, Helen Diller Family Comprehensive Cancer Center — San Francisco, California
• Sarcoma Oncology Center — Santa Monica, California
• University of Colorado — Aurora, Colorado
• Yale University School of Medicine — New Haven, Connecticut
• Johns Hopkins University, Sibley Memorial Hospital — Washington D.C., District of Columbia
• Mayo Clinic — Jacksonville, Florida
• Florida Cancer Specialists — Lake Mary, Florida
• Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland
• Massachusetts General Hospital — Boston, Massachusetts
• Dana Farber Cancer Institute — Boston, Massachusetts
• M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota
• Mayo Clinic — Rochester, Minnesota
• Washington University School of Medicine — St Louis, Missouri
• Memorial Sloan Kettering Cancer Center — New York, New York
• Duke University — Durham, North Carolina
• University Hospitals Cleveland Medical Center, Seidman Cancer Center — Cleveland, Ohio
• Cleveland Clinic — Cleveland, Ohio
• Oregon Health and Science University — Portland, Oregon
• University of Pennsylvania, Perelman School of Medicine — Philadelphia, Pennsylvania
• University of Pittsburgh Medical Center, Hillman Cancer Center — Pittsburgh, Pennsylvania

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.