Phase 12 Study of FOG-001 Treatment for Advanced or Metastatic Solid Tumors and Familial Adenomatous Polyposis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of FOG-001 in people with advanced or metastatic solid tumors and familial adenomatous polyposis FAP, a genetic condition affecting the Wnt pathway. This Phase 12 trial studies FOG-001 alone and combined with other anticancer drugs in patients with tumors that have Wnt pathway activating mutations or related colorectal cancers. The trial aims to understand how the drug behaves in the body, its safety, and its ability to control or reduce tumors. Participants receive FOG-001 through intravenous or subcutaneous administration in continuous 28-day cycles. Some groups also receive combinations of FOG-001 with other cancer treatments like mFOLFOX-6, Nivolumab, Trifluridinetipiracil, or Bevacizumab. The study includes dose escalation and dose expansion phases to find the recommended dose and evaluate effects across different tumor types and genetic profiles. Different subgroups focus on specific cancers such as colorectal cancer, hepatocellular carcinoma, desmoid tumors, prostate cancer, and FAP. During the trial, participants undergo regular assessments including scans, biopsies, and blood tests to monitor safety, drug levels, and tumor response. Researchers measure side effects, tumor shrinkage, disease control, and specific cancer markers over about 10 months. The study tracks overall response using RECIST criteria and evaluates pharmacokinetics and pharmacodynamics. Safety is closely monitored, and participants may have follow-up evaluations after treatment cycles. The total duration varies by participant depending on treatment and response.

FOG-001 in Locally Advanced or Metastatic Solid Tumors