Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Adequate organ and marrow function.

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).

Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.

Disqualifiers

Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC.

Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.

Osteoporosis, which is defined as a T-score of ≤-2.5 at the lumbar spine (L1 - L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan.

Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)

Trial design

Treatments tested in this trial

  • FOG-001
  • mFOLFOX-6
  • Nivolumab
  • Trifluridine/tipiracil
  • Bevacizumab
  • FOG-001

Treatment groups

595 Participants
are divided into 18 treatment groups

18

Treatment groups

See each treatment group below.

Locations

33
Australia
Integrated Clinical Oncology Network (ICON)4101, South BrisbaneQueensland, Australia
Peter MacCallum Cancer Centre3000, MelbourneVictoria, Australia
United States
Arizona
Mayo Clinic85054, Phoenix United States
Honor Health85258, Scottsdale United States

Sponsors and collaborators

Parabilis Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov