Study on Balstilimab, Botensilimab, and agenT-797 for Treating Colorectal Cancer with Liver Metastases
Sponsor: Darren Sigal, MD
ClinicalTrials ID:NCT07550088
This clinical trial is testing a combination of three drugs—balstilimab, botensilimab, and agenT-797—to see if they are safe and effective in treating adults with colorectal cancer that has spread to the liver and is not responding to previous treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to find out if a new combination of drugs—balstilimab, botensilimab, and agenT-797—can help shrink tumors in adults with colorectal cancer that has spread to the liver and is microsatellite stable (pMMR). The study will also look at what side effects might occur with this treatment. All participants will receive the combination treatment and will be monitored through imaging scans, blood tests, and follow-up visits to assess their response and any side effects.
Description
This study is testing a new treatment for colorectal cancer that has spread to the liver and is not responding to other treatments. The treatment combines three drugs: balstilimab, botensilimab, and agenT-797. The study aims to see if this combination can shrink tumors and improve outcomes for patients.
Participants will receive the treatment in cycles lasting 42 days, for up to nine cycles, or until the cancer progresses or side effects become too severe. During the study, participants will have regular imaging scans to check the size of their tumors and blood tests to monitor their health and look for specific markers related to the cancer.
The study will also collect tumor tissue samples to help researchers understand how the treatment works. After completing the treatment, participants will have follow-up visits to monitor their health and survival.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with colorectal cancer that has spread to the liver.
- Cancer must be microsatellite stable (pMMR) and confirmed by specific tests.
- Must have received at least one prior treatment for colorectal cancer.
- Must have at least one measurable tumor in the liver.
- Good overall health with a performance status of 0 or 1.
- Adequate organ function as shown by specific blood tests.
- Willing to provide informed consent and follow study procedures.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
Exclusion Criteria
- Cancer that is microsatellite instability-high (MSI-high).
- Previous treatment with certain immunotherapy drugs.
- Recent or current bowel obstruction.
- Significant heart disease or uncontrolled heart conditions.
- Active or untreated brain cancer.
- Other active cancers requiring treatment.
- Recent treatment with other cancer therapies.
- Known allergies to study drugs.
- History of lung disease requiring steroids.
- Previous organ or stem cell transplant.
- Active autoimmune disease requiring treatment.
- Active infections, including HIV, hepatitis B or C.
- Recent COVID-19 infection.
- Uncontrolled high blood pressure or other serious medical conditions.
- Pregnant or breastfeeding women, or those planning to become pregnant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Scripps Clinic Torrey Pines | 92037 | La Jolla | California |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.