Study on the Safety and Effectiveness of Tegavivint for Patients with Advanced Colorectal Cancer
Sponsor: HonorHealth Research Institute
ClinicalTrials ID:NCT07463599
This clinical trial is testing a new drug, Tegavivint, to see if it is safe and effective for treating patients with advanced colorectal cancer that has spread to other parts of the body. The study will look at how well the drug works on its own and in combination with standard 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 Tegavivint in patients with advanced colorectal cancer that has spread (metastatic colorectal carcinoma). The trial will test Tegavivint alone and in combination with other standard cancer treatments to see how well it works and how safe it is for patients.
Description
This study is divided into several parts and aims to find the best dose of Tegavivint for treating advanced colorectal cancer.
In the first part, the study will test different doses of Tegavivint given by IV to find the highest dose that patients can tolerate without severe side effects. This part will involve 9 to 18 patients.
Once the best dose is found, the second part will involve up to 24 patients to see how well Tegavivint works on its own.
In the third part, the study will test Tegavivint in combination with other standard cancer treatments to find the best dose for these combinations.
Finally, the fourth part will involve two groups of up to 24 patients each to see how effective these combination treatments are.
Throughout the study, researchers will monitor patients for side effects and how well the cancer responds to the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of metastatic colorectal cancer.
- Cancer must have progressed after at least two previous treatments.
- Must have measurable cancer that can be tracked.
- Willing to provide tumor samples for research.
- In good overall health with a performance status of 0 or 1.
- Have adequate organ and blood function based on specific tests.
- Must not have received cancer treatment recently, with specific timeframes for different treatments.
- Past Hepatitis C infection is allowed if treated and under control.
- Controlled Hepatitis B infection is allowed if under treatment and viral load is low.
- Blood pressure must be controlled.
- Must agree to use effective birth control during and after the study if of childbearing potential.
Exclusion Criteria
- Currently receiving other cancer treatments or experimental drugs.
- Taking certain medications that affect how the body processes drugs.
- Have a history of certain genetic conditions or allergies to similar drugs.
- Have another type of cancer, except for certain skin cancers or in situ cancers that have been treated.
- Have difficulty with drug administration or sample collection.
- Have central nervous system involvement or active infections.
- Have certain heart conditions or recent heart events.
- Pregnant or breastfeeding women cannot participate.
- Must agree to use effective contraception if of childbearing potential.
- Any other significant health condition that might interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clinical Trials Nurse Navigator | 85258 | Scottsdale | Arizona |
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