Study on CBX-12 for Treating Advanced Colorectal Cancer That No Longer Responds to Chemotherapy
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06730100
This clinical trial is testing a new drug, CBX-12, to see if it can help treat colorectal cancer that has spread and is not responding to standard chemotherapy. The study aims to find out if CBX-12 can work better than current treatments for this type of cancer.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of a new drug called CBX-12 for patients with colorectal cancer that has spread to other parts of the body and is no longer responding to chemotherapy. CBX-12 is designed to target and kill cancer cells more effectively by delivering a cancer-fighting substance directly into the tumor cells. The study will compare how well CBX-12 works against the usual treatments for this type of cancer.
Description
The main goal of this study is to see how well CBX-12 works in shrinking tumors in patients with advanced colorectal cancer that is resistant to chemotherapy. Researchers will also look at how the drug affects the progression of the disease and how long patients can live without the cancer getting worse.
Patients will receive CBX-12 through an IV infusion every 21 days, as long as the cancer does not progress or side effects are manageable. Throughout the study, patients will undergo various tests, including x-rays, CT scans, MRIs, and blood tests, to monitor their response to the treatment. Some patients may also have biopsies taken.
After finishing the treatment, patients will have follow-up visits at 30 days and then every three months for a year or until they pass away.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of metastatic colorectal cancer that is not responding to chemotherapy.
- Have at least one tumor that can be measured by scans or exams.
- Have recovered from any significant side effects of previous treatments.
- Provide a previous tumor sample for analysis.
- Have tried at least two standard treatments for colorectal cancer without success.
- Be 18 years or older.
- Be in good overall health with a performance status that allows for daily activities.
- Have adequate blood cell counts and organ function.
- HIV-positive patients must have an undetectable viral load.
- Hepatitis B and C patients must have controlled or cured infections.
- Patients with stable brain metastases are eligible.
- Agree to use effective contraception during and after the study.
- Be able to understand and sign a consent form.
Exclusion Criteria
- Have not fully recovered from side effects of previous cancer treatments.
- Are taking other experimental drugs.
- Have allergies to similar drugs as CBX-12.
- Are taking medications that could interact with CBX-12.
- Have uncontrolled illnesses that could make the study unsafe.
- Are pregnant or breastfeeding, due to potential risks to the baby.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | 92612 | Irvine | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| UF Health Cancer Institute - Gainesville | 32610 | Gainesville | Florida |
| Northwestern University | 60611 | Chicago | Illinois |
| Johns Hopkins University/Sidney Kimmel Cancer Center | 21287 | Baltimore | Maryland |
| Montefiore Medical Center-Einstein Campus | 10461 | The Bronx | New York |
| University of Cincinnati Cancer Center-UC Medical Center | 45219 | Cincinnati | Ohio |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| University of Cincinnati Cancer Center-West Chester | 45069 | West Chester | Ohio |
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