Actively Recruiting
Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer
Led by City of Hope Medical Center · Updated on 2025-05-30
24
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of metastatic colon, rectal, or breast cancer confirmed by pathology
- Colorectal or breast cancer producing carcinoembryonic antigen (CEA) with baseline or prior documented CEA level over 5 ng/ml or positive staining by immunohistochemistry
- Age 18 years or older
- Willing and able to provide informed consent and comply with study requirements
- Failed standard systemic therapy or no standard/curative systemic therapy exists, is intolerable, or was refused
- At least 4 weeks since last cytotoxic or biological treatment before SBRT (6 weeks if mitomycin C)
- Unresectable disease or not a candidate for surgery
- Minimum 1 and maximum 5 metastatic lesions planned for SBRT, each 5 cm or smaller, measurable per RECIST 1.1, excluding intracranial or bone sites
- At least 4 weeks since last radiation therapy before SBRT
- At least 4 weeks since last investigational therapy before SBRT (3 months if prior immunotherapy)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Clinically stable with expected survival of at least 3 months
- Neutrophils above 1500/mm^3
- Lymphocytes above 500/mm^3
- Hemoglobin above 9 gm/dl
- Platelets above 100,000/mm^3
- AST/ALT less than 2.5 times upper limit of normal
- Bilirubin at or below upper limit of normal
- Adequate kidney function with serum creatinine less than upper limit of normal or creatinine clearance over 60 ml/min
- Adequate cardiac function with no recent acute coronary syndrome, no significant arrhythmias or heart failure, controlled blood pressure, normal EKG with QTc limits
- Adequate pulmonary function without uncontrolled pleural effusion or oxygen dependence
- Left ventricular ejection fraction over 40% by echocardiogram
- Urinalysis showing no or minimal proteinuria
- Women of childbearing potential agree to use highly effective contraception during and after treatment
You will not qualify if you...
- Use of immunosuppressive treatments including high-dose corticosteroids
- History of autoimmune diseases including inflammatory bowel disease
- Active brain metastases
- Women of childbearing age refusing birth control methods
- Lactating women unwilling to stop breastfeeding
- Known active hepatitis B or C infection
- Major surgery within 4 weeks before SBRT
- Non-healed wounds or surgical incisions
- Radiographic evidence of bowel obstruction
- Uncorrectable electrolyte imbalances
- Known allergy to study drugs or components
- Uncontrolled illnesses including active infections
- History of allergic reactions to similar compounds
- Pregnancy
- Other active cancers
- Inability to comply with safety monitoring as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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