Study on AVZO-103 for Treating Advanced Urothelial Cancer and Other Solid Tumors
Sponsor: Avenzo Therapeutics, Inc.
ClinicalTrials ID:NCT07193511
This clinical trial is testing a new drug, AVZO-103, to see if it is safe and effective for patients with advanced urothelial cancer and other solid tumors. The study will look at how the drug works alone and in combination with other treatments.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug called AVZO-103 in patients with advanced urothelial cancer and other solid tumors. This is the first time AVZO-103 is being tested in humans. The study will determine the best dose of the drug when used alone and in combination with other treatments, and will assess its ability to shrink tumors.
Description
The study is divided into two phases:
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Phase 1: This phase will test different doses of AVZO-103 to find the highest dose that can be given safely without causing severe side effects. This phase will also help decide the best dose to use in future studies. The focus is on understanding how the drug is tolerated by patients and how it behaves in the body.
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Phase 2: This phase will explore how well AVZO-103 works in shrinking tumors when used alone and in combination with other treatments. Researchers will look at the drug's effectiveness in treating advanced urothelial cancer and other solid tumors.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a good overall health status, with a performance score of 1 or less, and a life expectancy of more than 3 months.
- Must have a confirmed diagnosis of advanced or metastatic urothelial cancer or other solid tumors.
- Must have measurable disease that can be evaluated by doctors.
- Must agree to provide test results and tumor samples for study purposes.
Exclusion Criteria
- Cannot have active cancer that has spread to the brain or central nervous system, unless it is treated and stable for at least 4 weeks without needing steroids.
- Cannot have a history of severe skin reactions like Stevens-Johnson syndrome.
- Cannot have a history of lung disease caused by drugs.
- Cannot have serious heart conditions.
- Cannot have had a recent infection requiring strong antibiotics or antiviral medications.
- Cannot have had a stem cell or organ transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Avenzo Therapeutics Recruiting Site | 32827 | Orlando | Florida |
| Avenzo Therapeutics Recruiting Site | 29572 | Myrtle Beach | South Carolina |
| Avenzo Therapeutics Recruiting Site | 37203 | Nashville | Tennessee |
| Avenzo Therapeutics Recruiting Site | 78758 | Austin | Texas |
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