OncoMatch/Clinical Trials/NCT05919264
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Is NCT05919264 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments for cancer.
Treatment: FOG-001 · mFOLFOX-6 · Nivolumab · Trifluridine/tipiracil · Bevacizumab — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Tumor Agnostic
Colorectal Cancer
Hepatocellular Carcinoma
Prostate Cancer
Endometrial Cancer
Biomarker criteria
Required: APC loss-of-function mutation
Participants with tumors known to be negative for APC LoF mutations ... are not eligible
Required: CTNNB1 gain-of-function mutation
Participants with tumors known to be negative for ... CTNNB1 GoF mutations (per NGS tests) are not eligible
Required: APC mutation
Diagnosis of phenotypic classical FAP with a documented APC mutation
Required: WNT pathway activating mutation
solid tumor with documented WNT- pathway activating mutations (WPAMs)
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status of 0 or 1
Prior therapy
Cannot have received: complete colectomy
Exception: allowed if >6 months prior to first dose
Complete colectomy within 6 months of the first dose of study drug administration
Lab requirements
Blood counts
Adequate organ and marrow function
Cardiac function
Unstable/inadequate cardiac function [excluded]
Adequate organ and marrow function. Unstable/inadequate cardiac function [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05919264 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior complete colectomy disqualifies patients from enrollment.
Does this trial require APC?
Yes, APC loss-of-function mutation is a required biomarker for enrollment.
Does this trial require CTNNB1?
Yes, CTNNB1 gain-of-function mutation is a required biomarker for enrollment.
Does this trial require APC?
Yes, APC mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify