RecruitingPhase 1NCT06130826

Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer

A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer


Sponsor

City of Hope Medical Center

Enrollment

24 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects and best dose of M5A-IL2 immunocytokine (M5A-ICK) combined with stereotactic body radiation therapy (SBRT) and to see how well they work in treating patients with colorectal cancer or xarcinoembryonic antigen (CEA) positive breast cancer that cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). Carcinoembryonic Antigen (CEA) is a protein that is present in most colorectal cancers and in many other cancers, such as breast cancer, as well. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Cytokines are signaling proteins that help control inflammation in the body. They allow the immune system to mount a defense if germs or cancer or other substances that can make people sick enter the body. Interleukin-2 (IL-2) is a powerful cytokine able to regulate the immune responses that are important for anticancer immunity. Immunocytokines (also called antibody-cytokine fusion proteins) are small proteins that regulate the activity of immune cells. The M5A-IL2 immunocytokine (M5A-ICK) combines the cancer targeting features of the M5A antibody with the immune system regulation properties of the cytokine IL-2. Giving M5A-ICK in combination with standard of care (SOC) SBRT may work better in treating patients with unresectable metastatic colorectal cancer or CEA positive metastatic breast cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of targeted radiation therapy (SBRT) with an experimental immune-stimulating antibody (M5A-IL2) to try to trigger the immune system to attack cancer in people with advanced colorectal cancer or breast cancer that produces a protein called CEA. The idea is that radiation can expose cancer cells, and the immune drug can then help the body fight the cancer more broadly. **You may be eligible if...** - You are 18 or older with advanced (metastatic) colorectal or breast cancer - Your cancer produces CEA (a protein detectable by blood test or biopsy staining) - Standard treatments have failed, are not tolerable, or don't exist for your cancer - You have 1 to 5 measurable metastatic tumors that can be treated with radiation - Your blood counts, liver, kidneys, and heart function are adequate **You may NOT be eligible if...** - You are on immunosuppressive medications or steroids - You have a history of autoimmune disease or inflammatory bowel disease - You have brain metastases - You are pregnant or breastfeeding - You have active hepatitis B or C - You have had major surgery within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo tissue biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGImmunotherapy

Receive M5A-IL2 ICK SC

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06130826


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