OncoMatch

OncoMatch/Clinical Trials/NCT05919264

FOG-001 in Locally Advanced or Metastatic Solid Tumors

Is NCT05919264 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for cancer.

Phase 1/2RecruitingParabilis Medicines, Inc.NCT05919264Data as of Jun 2026

Treatment: FOG-001 · mFOLFOX-6 · Nivolumab · Trifluridine/tipiracil · BevacizumabThe goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Nivolumab

Targeted therapy

Bevacizumab

Other

FOG-001mFOLFOX-6Trifluridine/tipiracil

Cancer type

Colorectal Cancer

Tumor Agnostic

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 ... are not eligible

Disease stage

Required: Stage III, IV

Diagnosis of treatment-refractory advanced/metastatic solid tumor; locally advanced or metastatic non-MSI-H or non-dMMR CRC

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

Unstable/inadequate cardiac function excluded

Adequate organ and marrow function. Unstable/inadequate cardiac function.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Honor Health · Scottsdale, Arizona
  • Arizona Cancer Center at University of Arizona · Tucson, Arizona
  • 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

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.

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.

What disease stage is eligible?

Stage III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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