Study on FOG-001 for Advanced or Metastatic Solid Tumors
Sponsor: Fog Pharmaceuticals, Inc.
ClinicalTrials ID:NCT05919264
This clinical trial is testing a new drug, FOG-001, to see if it is safe and effective for people with advanced or metastatic solid tumors. The study focuses on how the drug works in the body and its ability to fight cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug called FOG-001 in people with advanced or metastatic solid tumors. FOG-001 is a new type of treatment that targets a protein called Beta-catenin, which is involved in cancer growth. The study will look at how well the drug is tolerated, how it behaves in the body, and its potential to reduce tumors.
Description
This clinical trial is the first time FOG-001 is being tested in humans. It is a Phase 1/2 study conducted at multiple centers, where participants will receive the drug to see how safe it is and how well it works against cancer. FOG-001 is designed to block a protein called Beta-catenin, which plays a role in cancer cell growth. The study will involve different groups of participants to find the best dose and to see how the drug affects the body and the cancer. Participants will be closely monitored for any side effects and the drug's impact on their cancer.
Eligibility Criteria
Inclusion Criteria
- Must be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ and bone marrow function.
For Dose Escalation Groups (Part 1a):
- Have advanced or metastatic solid tumors that have not responded to treatment, specifically non-MSI-H or non-dMMR colorectal cancer or other solid tumors with specific genetic changes in the WNT pathway.
For Dose Escalation Groups (Part 1b):
- Have advanced or metastatic non-MSI-H or non-dMMR colorectal cancer.
- Have at least one tumor that can be biopsied.
For Dose Expansion Group (Cohort 2a):
- Have advanced or metastatic non-MSI-H or non-dMMR colorectal cancer.
For Dose Expansion Group (Cohort 2b):
- Have advanced or metastatic non-small cell lung cancer with specific genetic changes in APC or Beta-catenin.
For Dose Expansion Group (Cohort 2c):
- Have advanced or metastatic gastric or gastroesophageal junction cancer with specific genetic changes in APC or Beta-catenin.
For Dose Expansion Group (Cohort 2d):
- Have advanced or metastatic solid tumors with specific genetic changes in the WNT pathway.
Exclusion Criteria
- Have a history of cancer spreading to the bones.
- Have had a vertebral compression fracture or non-traumatic bone fracture in the past year and are not receiving treatment for bone health.
- Have osteoporosis, as determined by specific bone density tests or fracture risk assessments.
- Have active inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, that requires treatment.
- Have unstable or inadequate heart function.
- Have cancer that has spread to the brain or spinal cord, causing symptoms or instability.
- Are pregnant, breastfeeding, or planning to become pregnant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Honor Health | 85258 | Scottsdale | Arizona |
| Yale University School of Medicine | 06520 | New Haven | Connecticut |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Washington University School of Medicine | 63110 | Saint Louis | Missouri |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Oregon Health and Science University | 97239 | Portland | Oregon |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
| South Texas Accelerated Research Therapeutics, LLC | 78229 | San Antonio | Texas |
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