NCT05919264 · Parabilis Medicines, Inc.
FOG-001 in Locally Advanced or Metastatic Solid Tumors
What this study 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 cancer.
View original scientific description
The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.
Interventions
DRUG
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
DRUG
mFOLFOX-6
mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
DRUG
Nivolumab
Nivolumab will be administered per the prescribing information in combination with FOG-001
DRUG
Trifluridine/tipiracil
Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
DRUG
Bevacizumab
Bevacizumab will be administered per the prescribing information in combination with FOG-001
DRUG
FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Primary outcome measures
During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0
Time frame: Through study completion, an average of 10 months
Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0
During dose escalation characterize dose-limiting toxicities (DLTs)
Time frame: 1 treatment cycle (28 days)
Incidence of DLTs
During dose expansion describe the Overall Response Rate using RECIST v1.1
Time frame: Every 63 days until study completion, approximately 10 months on average
The rate of objective responses (Partial \& Complete) using RECIST v1.1
During dose expansion describe the Disease Control Rate using RECIST v1.1 (Part 2a only)
Time frame: 4 months
The rate of objective responses (Stable, Partial, \& Complete) using RECIST v1.1
During dose expansion describe the PSA30 response rate for participants with prostate cancer
Time frame: Baseline, weekly during the first 2 cycles (56 days), bi-weekly during the Cycle 3 (28 days), and then monthly (up to approximately 7 months)
The response to treatment as a 30% or greater reduction in PSA levels from baseline
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Escalatio
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Los Angeles, California
- Palo Alto, California
- San Francisco, California
- Santa Monica, California
- Aurora, Colorado
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Lake Mary, Florida
And 16 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations