Clinical Trials | A Phase 1 /2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have been diagnosed with cancer that is locally advanced (means disease has grown larger and spread beyond where it originally started, but it has not traveled to other parts of the body) or is metastatic (means the disease has spread to other parts of the body). This study is focusing on patients with colorectal cancer, desmoid tumors, prostate cancer and those with solid tumors with Wnt pathway activating mutations. The purpose of this study is to test a new study drug, FOG-001. This drug is being tested in humans for the first time. The goals of this study are to see how safe and tolerable FOG-001 is when given alone and together with other anticancer drugs at different dose levels in participants, and to determine the optimal dose of FOG-001 when given alone and together with other cancer drugs. This study consists of 2 parts: • Part 1 (Dose Escalation): In part 1, the purpose is to find the safest and most active dose of the FOG-001 to give to the participants, when given alone or in combination with other anticancer drugs. • Part 2 (Dose Expansion): In part 2, the purpose is to further evaluate the safest and most active dose of FOG-001 in participants, when given alone or in combination with other anticancer drugs. For both part 1 and part 2, if you are assigned to a study part with other drugs, your study doctor will let you know which drugs you are receiving in addition to FOG-001. You will receive FOG-001 via an IV infusion. During the study treatment period, you will receive the study treatment and undergo tests to monitor your health and safety and be evaluated to see if the cancer is responding to the study treatment. The treatment period is made up of 28-day cycles, and you will be in the study for up to approximately 10 months. Depending on you tolerate the study treatment, you may remain in the study longer than 10 months. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT05919264 [email protected]