RecruitingCancerColorectal CancerSolid Tumor

FOG-001 in Locally Advanced or Metastatic Solid Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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.

Sponsor: Parabilis Medicines, Inc.

✓ 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.
✓ 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):

✕ 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)
✕ Unstable/inadequate cardiac function.
✕ Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.
✕ Pregnant, lactating, or planning to become pregnant.