FOG-001 in Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors
Parabilis Medicines, Inc.
575 participants
May 23, 2023
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.
Eligibility
Inclusion Criteria17
- 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.
- At least one lesion that is suitable for a core needle biopsy.
- Diagnosis of HCC with a documented WPAM (by local testing) in APC or CTNNB1. HCC that is radiographically confirmed without tissue biopsy may be enrolled with a documented CTNNB1 mutation (e.g., by ctDNA).
- Desmoid tumor (aggressive fibromatosis)
- Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC
- Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.
- One dose of mFOLFOX6 in the unresectable or metastatic setting prior to enrollment is allowed.
- Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.
- MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1/PD-L1
- Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible
- Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC
- Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.
- Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC
- Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence
Exclusion Criteria7
- 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.
Interventions
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
Nivolumab will be administered per the prescribing information in combination with FOG-001
Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
Bevacizumab will be administered per the prescribing information in combination with FOG-001
Locations(23)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05919264