NCT05919264
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Recruiting · Phase 1, Phase 2 · Parabilis Medicines, Inc. · registry updated 2026-10-07
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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).
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and marrow function.
- Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g):
- 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):
- Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
Exclusion
- Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC. For participants with FAP, osteomas are allowed.
- 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)
- Unstable/inadequate cardiac function.
- Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.