Testing the Targeted Therapy FOG-001 for Advanced Cancers in People with APC Mutations and FAP
Treatment
Treatment study for people with advanced cancers or desmoid tumors and FAP
Clinicaltrials.gov identifier:NCT05919264
About the Study
This clinical trial is testing a new targeted treatment called FOG-001 (zolucatetide) for people with advanced cancers linked to changes in the gene or related pathways. These changes are common in colorectal cancers that develop in people with familial adenomatous polyposis (FAP). The study will look at whether FOG-001 is safe and whether it can help slow the growth of cancer or shrink tumors.
People with FAP have an increased risk of colorectal cancer due to inherited mutations. FOG-001 is designed to target the WNT pathway, which becomes overactive when the gene is no longer working properly. Researchers hope this approach may provide a new treatment option for cancers driven by mutations.
The study is also enrolling people with other tumors linked to WNT pathway mutations, including desmoid tumors, which can occur in some people with FAP and other syndromes.
This Study is Open To:
This Study is NOT Open To:
What the Study Involves
Participants will receive FOG-001, either alone or in combination with other cancer treatments, depending on which study group they enroll in. Treatment combinations may include chemotherapy, , or other targeted therapies.
During the study, participants will:
- Receive FOG-001 and other study treatments as assigned.
- Have regular physical exams and blood tests to monitor their health and look for side effects.
- Undergo imaging tests, such as CT or scans, to see whether their cancer is responding to treatment.
- Provide information about any symptoms or side effects they experience.
- In some study groups, provide tumor samples or undergo biopsies to help researchers understand how the treatment affects cancers with mutations and other WNT pathway changes.
Researchers will continue to monitor participants throughout the study to evaluate the safety of FOG-001 and determine whether it can slow cancer growth or shrink tumors.
Locations:
Arizona
City: Phoenix RECRUITING
Facility: Mayo Clinic
Contact Info:
480-301-8000
City: Scottsdale RECRUITING
Facility: Honor Health
Contact Info:
480-323-1350
City: Tucson RECRUITING
Facility: Arizona Cancer Center at University of Arizona
Contact Info:
520-694-2873
California
City: Los Angeles RECRUITING
Facility: University of California, Los Angeles (UCLA)
Contact Info:
310-829-5471
City: Palo Alto RECRUITING
Facility: Stanford Cancer Institute, Stanford University
Contact Info:
650-498-6000
City: San Francisco RECRUITING
Facility: University of California San Francisco, Helen Diller Family Comprehensive Cancer Center
Contact Info:
888-689-8273
City: Santa Monica RECRUITING
Facility: Sarcoma Oncology Center
Contact Info:
301-552-9999
Colorado
City: Aurora RECRUITING
Facility: University of Colorado
Contact Info:
305-243-1287
Connecticut
City: New Haven RECRUITING
Facility: Yale University School of Medicine
Contact Info:
415-302-7807
District of Columbia
City: Washington D.C. RECRUITING
Facility: Johns Hopkins University, Sibley Memorial Hospital
Contact Info:
202-804-3343
Florida
City: Jacksonville RECRUITING
Facility: Mayo Clinic
Contact Info:
904-953-6870
Massachusetts
City: Boston RECRUITING
Facility: Massachusetts General Hospital
Contact Info:
617-724-4000
City: Boston RECRUITING
Facility: Dana Farber Cancer Institute
Contact Info:
617-632-3000
Maryland
City: Baltimore RECRUITING
Facility: Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center
Contact Info:
410-955-8964
410-955-8964
Minnesota
City: Minneapolis RECRUITING
Facility: M Health Fairview University of Minnesota Medical Center
Contact Info:
612-273-8383
City: Rochester RECRUITING
Facility: Mayo Clinic
Contact Info:
504-284-2511
Missouri
City: St Louis RECRUITING
Facility: Washington University School of Medicine
Contact Info:
314-362-9115
North Carolina
City: Durham RECRUITING
Facility: Duke University
Contact Info:
919-684-6342
New York
City: New York RECRUITING
Facility: Memorial Sloan Kettering Cancer Center
Contact Info:
646-888-5109
Ohio
City: Cleveland RECRUITING
Facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center
Contact Info:
216-765-9033
City: Cleveland RECRUITING
Facility: Cleveland Clinic
Contact Info:
216-444-2200
(216) 444-2200
Oregon
City: Portland RECRUITING
Facility: Oregon Health and Science University
Contact Info:
503-494-8534
Pennsylvania
City: Philadelphia RECRUITING
Facility: University of Pennsylvania, Perelman School of Medicine
Contact Info:
215-662-4646
City: Pittsburgh RECRUITING
Facility: University of Pittsburgh Medical Center, Hillman Cancer Center
Contact Info:
412-623-1722
Tennessee
City: Nashville RECRUITING
Facility: Sarah Cannon Research Institute
Contact Info:
615-329-6862
City: Nashville RECRUITING
Facility: Vanderbilt Ingram Cancer Center
Contact Info:
615-322-3000
Texas
City: Houston RECRUITING
Facility: The University of Texas MD Anderson Cancer Center
Contact Info:
713-792-5603
City: San Antonio RECRUITING
Facility: South Texas Accelerated Research Therapeutics, LLC
Contact Info:
210-593-5255
Virginia
City: Charlottesville RECRUITING
Facility: University of Virginia
Contact Info:
434-358-8780
Wisconsin
City: Madison RECRUITING
Facility: University of Wisconsin, Carbone Cancer Center
Contact Info:
608-263-1300
Other Countries
Country: Australia
State: Queensland
City: South Brisbane RECRUITING
Facility: Integrated Clinical Oncology Network (ICON)
Contact Info:
+61755198211
Country: Australia
State: Victoria
City: Melbourne RECRUITING
Facility: Peter MacCallum Cancer Centre
Contact Info:
+61385595000
Treatment
Treatment study for people with advanced cancers or desmoid tumors and FAP
Clinicaltrials.gov identifier:NCT05919264