Actively Recruiting
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Led by Parabilis Medicines, Inc. · Updated on 2026-05-12
595
Participants Needed
29
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or any other solid tumor with documented Wnt pathway activating mutations (WPAMs) (Part 1a and Part 1g)
- Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR colorectal cancer with at least one lesion suitable for core needle biopsy (Part 1b)
- Histologically, cytologically, or radiographically confirmed hepatocellular carcinoma with documented WPAM in APC or CTNNB1 (Part 1c and Part 2c)
- Diagnosis of desmoid tumor (aggressive fibromatosis) (Part 1d, Part 1h, and Part 2d)
- Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR colorectal cancer for FOG-001 + FOLFOX + Bevacizumab cohorts; prior one dose of mFOLFOX6 allowed; tumors must not be negative for APC LoF or CTNNB1 GoF mutations (Part 1f-1 and Part 2f-1)
- Non-MSI-H or non-dMMR colorectal cancer with or without liver metastases for FOG-001 + Nivolumab cohorts; tumors must not be negative for APC LoF or CTNNB1 GoF mutations (Part 1f-2 and Part 2f-2)
- Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR colorectal cancer for FOG-001 + Trifluridine/Tipiracil + Bevacizumab cohorts; tumors must not be negative for APC LoF or CTNNB1 GoF mutations (Part 1f-3 and Part 2f-3)
- Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR colorectal cancer (Part 2a)
- Diagnosis of advanced or metastatic solid tumors with documented WPAM or equivalent evidence (Part 2b)
You will not qualify if you...
- Known history of bone metastasis except for patients with metastatic castration-resistant prostate cancer
- Vertebral compression fracture or non-traumatic bone fracture within the past 12 months without antiresorptive therapy
- Osteoporosis defined as T-score 3-2.5 at lumbar spine, femoral neck, or total hip by DXA scan
- Uncontrolled inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- Unstable or inadequate cardiac function
- Known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases
- Pregnant, lactating, or planning to become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Arizona Cancer Center at University of Arizona
Tucson, Arizona, United States, 85719
Actively Recruiting
3
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Actively Recruiting
4
Stanford Cancer Institute, Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
5
University of California San Francisco, Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
6
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
7
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
8
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Actively Recruiting
9
Johns Hopkins University, Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
10
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
Terminated
11
Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
13
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
14
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
15
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
16
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
17
University Hospitals Cleveland Medical Center, Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
18
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
19
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
20
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
21
University of Pittsburgh Medical Center, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
22
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
23
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
24
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
25
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
26
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
27
University of Wisconsin, Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
28
Integrated Clinical Oncology Network (ICON)
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
29
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
C
Clinical Trial Inquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
18
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