FOG-001 in Locally Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
FOG-001: FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
mFOLFOX-6: mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
Nivolumab: Nivolumab will be administered per the prescribing information in combination with FOG-001
Trifluridine/tipiracil: Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
Bevacizumab: Bevacizumab will be administered per the prescribing information in combination with FOG-001
FOG-001: FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Study summary
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 or in participants with familial adenomatous polyposis (FAP).
Eligibility
Primary outcome measure(s)
- During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0 — 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) — 1 treatment cycle (28 days)
Incidence of DLTs - During dose expansion describe the Overall Response Rate using RECIST v1.1 — 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) — 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 — 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
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | Recruiting |
| Honor Health | Scottsdale | Arizona | Recruiting |
| Arizona Cancer Center at University of Arizona | Tucson | Arizona | Recruiting |
| University of California, Los Angeles (UCLA) | Los Angeles | California | Recruiting |
| Stanford Cancer Institute, Stanford University | Palo Alto | California | Recruiting |
| University of California San Francisco, Helen Diller Family Comprehensive Cancer Center | San Francisco | California | Recruiting |
| Sarcoma Oncology Center | Santa Monica | California | Recruiting |
| University of Colorado | Aurora | Colorado | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| Johns Hopkins University, Sibley Memorial Hospital | Washington D.C. | District of Columbia | Recruiting |
| Mayo Clinic | Jacksonville | Florida | Recruiting |
| Florida Cancer Specialists | Lake Mary | Florida | Terminated |
| Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| M Health Fairview University of Minnesota Medical Center | Minneapolis | Minnesota | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| University Hospitals Cleveland Medical Center, Seidman Cancer Center | Cleveland | Ohio | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Oregon Health and Science University | Portland | Oregon | Recruiting |
| University of Pennsylvania, Perelman School of Medicine | Philadelphia | Pennsylvania | Recruiting |
| University of Pittsburgh Medical Center, Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | Recruiting |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas | Recruiting |
| University of Virginia | Charlottesville | Virginia | Recruiting |
| University of Wisconsin, Carbone Cancer Center | Madison | Wisconsin | Recruiting |
| Integrated Clinical Oncology Network (ICON) | South Brisbane | Queensland | Recruiting |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05919264 on ClinicalTrials.gov ↗ ← All trials in the USA