OncoMatch/Clinical Trials/NCT06130826
Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer
Is NCT06130826 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Immunotherapy for breast carcinoma.
Treatment: Immunotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Colorectal Cancer
Biomarker criteria
Required: CEACAM5 CEA producing (CEA > 5 ng/ml or evidence of CEA staining by IHC)
CEA producing colorectal cancer or breast cancer defined as a baseline CEA or prior documented CEA level exceeding 5 ng/ml or evidence of CEA staining by Immunohistochemistry (IHC)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard systemic therapy
Patients who have failed to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist, is not tolerable or was refused
Lab requirements
Blood counts
Neutrophil count > 1500/mm^3; Lymphocyte count > 500/mm^3; Hemoglobin > 9 gm/dl; Platelets count > 100,000/mm^3
Kidney function
serum creatinine < ULN or calculated creatinine clearance > 60ml/min (Cockroft-Gault formula)
Liver function
AST/ALT < 2.5 x ULN; Bilirubin ≤ ULN
Cardiac function
No history of acute coronary syndromes < 12 months prior to screening; No impaired cardiovascular function or clinically significant cardiovascular diseases; No uncontrolled arterial hypertension (systolic > 160 or diastolic > 100); EKG showing normal sinus rhythm and QTc ≤ 450 ms for male and ≤ 470 ms for female; Screening 2-D echo shows LVEF > 40%
AST/ALT < 2.5 x ULN; Bilirubin ≤ ULN; serum creatinine < ULN or calculated creatinine clearance > 60ml/min; Neutrophil count > 1500/mm^3; Lymphocyte count > 500/mm^3; Hemoglobin > 9 gm/dl; Platelets count > 100,000/mm^3; cardiac function: see details; pulmonary function: see details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify