Study on the Safety and Effectiveness of SOT109 for Advanced Colorectal Cancer
Sponsor: SOTIO Biotech a.s.
ClinicalTrials ID:NCT07693751
This clinical trial is testing a new cancer treatment called SOT109, which targets specific cancer cells in advanced colorectal cancer. The study aims to find the safest and most effective dose of SOT109 for patients whose cancer cannot be surgically removed or has spread to other parts of the body.
Patient Parameters
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Program Overview
SOT109 is a new cancer drug designed to target and kill cancer cells with a specific marker, CDH17, while minimizing harm to healthy cells. The study has two parts: Part A focuses on understanding the effects and safety of SOT109 at different doses, while Part B aims to find the best dose that balances benefits and risks.
Description
The trial is divided into two parts:
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Part A: This part involves testing different doses of SOT109 in patients with advanced colorectal cancer that cannot be removed by surgery or has spread. The goal is to find the maximum safe dose and understand how the drug works in the body.
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Part B: After identifying safe doses in Part A, this part will compare two selected doses to find the best one that offers the most benefit with the least risk. This part will also evaluate the safety and effectiveness of SOT109 in patients who have no other standard treatment options available.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Able to understand and sign a consent form to participate.
- In good general health with a performance status score of 0 or 1.
- Expected to live at least 3 more months.
- Suitable for experimental therapy.
- Agree not to join other clinical trials during this study.
- Have adequate blood cell counts and organ function.
- Have advanced colorectal cancer that cannot be surgically removed or has spread.
- Have tried standard treatments without success.
- Women must not be pregnant and must use effective birth control during and after the study.
- Men must use condoms during and after the study.
Exclusion Criteria
- Recent radiation therapy or not fully recovered from its side effects.
- Have received other cancer treatments recently.
- Cannot receive other cancer treatments during the study.
- Recent vaccination with live vaccines.
- Recent blood transfusion.
- Severe preexisting medical conditions.
- History of lung diseases like pneumonitis or fibrosis.
- Active infections or untreated brain cancer.
- Known HIV, hepatitis B, or hepatitis C infections unless controlled.
- Substance abuse issues.
- Serious heart conditions or recent heart events.
- Recent major surgery or incomplete healing from surgery.
- Allergies to study medications.
- History of inflammatory bowel disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NEXT Houston | 77054 | Houston | Texas |
| NEXT Virginia | 22031 | Faifax | Virginia |
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