Testing the Targeted Therapy FOG-001 for Advanced Cancers in People with APC Mutations and FAP

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 APC 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 APC mutations. FOG-001 is designed to target the WNT pathway, which becomes overactive when the APC gene is no longer working properly. Researchers hope this approach may provide a new treatment option for cancers driven by APC 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 inherited cancer syndromes. 

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, immunotherapy, 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 MRI 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 APC 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.