- Recruiting
- Treatment
- Interventional
- Non Randomized
- Drug
- PHASE1/PHASE2
- Parabilis Medicines, Inc.
- 18 Years -
Study Purpose
The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.
Intervention
Drug : FOG-001
Drug : mFOLFOX-6
Drug : Nivolumab
Drug : Trifluridine/tipiracil
Drug : Bevacizumab
Eligibility Requirements
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 1e):
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):
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).
Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d and Part 2d):
Desmoid tumor (aggressive fibromatosis) with a documented WPAM (by local testing) in APC or CTNNB1.
Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:
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.
Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab
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
Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine/Tipiracil + Bevacizumab
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.
Additional Inclusion Criteria for Dose Expansion Cohort (Part 2a):
Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC
Additional Inclusion Criteria for Dose Expansion Cohort (Part 2b):
Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence
Minimum age: 18
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.
Inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease) that is recently active or requires therapy currently.
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.
Recruiting status
Recruiting
Estimated enrollment
480
Study start date
May 23, 2023
Study end date
Aug 31, 2027
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug
Study phase
PHASE1/PHASE2
Allocation
Non Randomized
Sponsor:
Parabilis Medicines, Inc.
Collaborator:
N/A
Investigator:
Marie Nguyen, MD
Publications
N/A
Websites
N/A
NCT05919264
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