Actively Recruiting
A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors
Led by Parabilis Medicines, Inc. · Updated on 2026-05-28
595
Participants Needed
33
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating FOG-001 for safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity in people with locally advanced or metastatic solid tumors that likely or known to have mutations activating the Wnt pathway. This first-in-human, phase 1/2, multicenter study includes dose escalation and expansion phases to assess FOG-001 alone and in combination with other cancer drugs. FOG-001 is given either intravenously or subcutaneously in continuous 28-day cycles. Some participants receive FOG-001 alone, while others receive it combined with mFOLFOX-6, Nivolumab, Trifluridine/tipiracil, or Bevacizumab according to prescribing information. Multiple study parts include treatment of various cancers such as colorectal, hepatocellular carcinoma, desmoid tumors, and prostate cancer, based on specific mutation status. Participants will undergo safety evaluations including monitoring for adverse events and dose-limiting toxicities over approximately 10 months. Tumor response is assessed regularly using imaging criteria, along with specific measurements like PSA30 for prostate cancer. Pharmacokinetic and pharmacodynamic tests are done during early cycles. The study involves frequent visits for treatment administration, scans, lab tests, biopsies, and clinical assessments to track treatment effects and safety throughout the study period.
CONDITIONS
Brief 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 with documented WNT-pathway activating mutations or non-MSI-H/non-dMMR colorectal cancer (CRC) for dose escalation cohorts
- At least one lesion suitable for core needle biopsy for certain dose escalation cohorts
- Histologically, cytologically, or radiographically confirmed hepatocellular carcinoma (HCC) with documented WPAM in APC or CTNNB1 for select cohorts
- Diagnosis of desmoid tumor (aggressive fibromatosis) for certain cohorts
- Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC with specific mutation status for combination therapy cohorts
- Diagnosis of advanced or metastatic solid tumors with documented WPAM or equivalent evidence for dose expansion cohorts
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 past 12 months without antiresorptive therapy
- Osteoporosis defined as T-score ≤ -2.5 at lumbar spine, femoral neck, or total hip by DXA scan
- Uncontrolled inflammatory bowel disease (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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive FOG-001 and may receive other anticancer agents according to assigned doses in continuous 28-day cycles to evaluate safety, tolerability, and antitumor activity.
Visits every 28 days for treatment administration with additional assessments every 63 days
Duration - Up to approximately 10 months on average after treatment
Participants are monitored for safety and disease status after treatment completion.
Visits approximately every 63 days for response and safety assessments
Trial Site Locations
Total: 33 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
Arizona Cancer Center at University of Arizona
Tucson, Arizona, United States, 85719
Actively Recruiting
4
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Actively Recruiting
5
Stanford Cancer Institute, Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
6
University of California San Francisco, Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
7
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
8
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Actively Recruiting
10
Johns Hopkins University, Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
11
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
12
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
Terminated
13
Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
14
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
15
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
16
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
17
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
18
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
19
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
20
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
21
University Hospitals Cleveland Medical Center, Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
22
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
23
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
24
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
University of Pittsburgh Medical Center, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
26
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
27
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
28
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
29
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
30
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
31
University of Wisconsin, Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
32
Integrated Clinical Oncology Network (ICON)
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
33
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
C
Clinical Trial Inquiries
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
18
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here