First-in-Human Study of VBC108 for Advanced Solid Tumors
Sponsor: VelaVigo Bio Inc
ClinicalTrials ID:NCT07700160
This clinical trial is testing a new drug, VBC108, to see if it is safe and effective for treating advanced solid tumors that cannot be surgically removed. The study will determine the best dose and evaluate how well the drug works in shrinking tumors.
Patient Parameters
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Program Overview
This study is the first to test a new drug called VBC108 in humans. It involves multiple centers and is open to participants with advanced solid tumors that cannot be removed by surgery. The trial is divided into two parts: the first part will find the best dose of VBC108, and the second part will test this dose in more patients to confirm its safety and effectiveness. The goal is to see if VBC108 can help reduce tumors in people with certain types of cancer.
Eligibility Criteria
Inclusion Criteria
- Willing to provide written consent to participate in the study.
- Have a confirmed diagnosis of advanced or metastatic solid tumor that cannot be surgically removed.
- Have at least one tumor that can be measured by scans.
- Be an adult aged 18 or older.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of more than 12 weeks.
- Have a previous tumor sample available or be willing to undergo a new biopsy.
- Have adequate organ and bone marrow function.
- Must have completed a minimum waiting period after previous cancer treatments before starting the study drug.
Exclusion Criteria
- Have any unresolved side effects from previous cancer treatments that are moderate or severe.
- Have known or suspected cancer spread to the brain or spinal cord.
- Have previously received treatments targeting specific proteins (CLDN18.2x CDH17) or certain types of cancer therapies (ADC with topoisomerase I inhibitor or CLDN18.2 CAR-T).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| START Midwest, LLC | 49546 | Grand Rapids | Michigan |
| Laura and Issac Perlmutter Cancer Center | 10016 | New York | New York |
| Next Oncology - Oncology | 78229 | San Antonio | Texas |
| NEXT Oncology Virginia | 22031 | Fairfax | Virginia |
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