M5A-IL2 Immunotherapy for Unresectable Metastatic Colorectal or CEA Positive Breast Cancer
This study is looking at a new treatment called M5A-IL2 immunocytokine (M5A-ICK) combined with stereotactic body radiation therapy (SBRT). SBRT is a precise type of radiation. This treatment is for people with colorectal cancer or breast cancer that has spread (metastatic) and cannot be removed by surgery. Your cancer must also produce a protein called Carcinoembryonic Antigen (CEA). The main goal is to find the safest and most effective dose of M5A-ICK. Researchers will also look at how well the treatment shrinks tumors and any side effects. This study aims to enroll 24 participants and its current status is unclear.
- Study design
- This is a dose-escalation study, meaning participants will receive increasing doses of M5A-ICK to find the safest and most effective amount. It plans to enroll 24 participants.
- What's involved
- You would undergo SBRT over 3 days, followed by M5A-ICK injections for 3 days. You will also have CT or PET/CT scans and blood tests throughout the trial, and possibly a bone scan or optional biopsies.
- Compensation
- Not stated in the trial record.
- Follow-up
- After completing the study treatment, you will have a follow-up visit at 3 months.
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NCT06130826
Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~24 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionBone ScanComputed TomographyImmunotherapyMagnetic Resonance Imaging
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) of the M5A-IL2 immunocytokine (M5A-ICK)
Measured over At the end of cycle 1 (each cycle is 28 days)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Jeffrey Y Wong · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients should have a diagnosis of metastatic colon or rectal or breast cancer that is pathology proven
Patients should have a 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)
Patients should 18 years of age or older
Patients are willing and capable to consent to study and to adhere with all elements of the study
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
Patients should be at least 4 weeks from last receipt of a cytotoxic or biological agent prior to start of SBRT, with the exception of mitomycin C which requires a 6-week washout
Patients should have unresectable disease or not be a candidate for surgical resection
Patients must have a minimum of 1 and a maximum of 5 separate metastatic lesions planned for SBRT. (Patients may have \> 5 metastatic lesions overall, however only up to 5 lesions will be treated with SBRT.) SBRT sites must be equal to or less than 5 cm in greatest dimension. SBRT treated sites must be measurable per RECIST 1.1 and can include metastatic sites in the lung, liver, or soft tissue. Sites that are intracranial or in the bone are excluded. Sites deemed not appropriate for SBRT by the treating radiation oncologist are also excluded
Patients should be at least 4 weeks from last radiation therapy prior to starting SBRT
Patients should be at least 4 weeks from any investigational therapy prior to starting SBRT, with the exception of prior immunotherapy which would require a 3 month washout
Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Patients should be considered clinically stable with an estimated overall survival of at least 3 months
Neutrophil count \> 1500/mm\^3
Lymphocyte count \> 500/mm\^3
Hemoglobin \> 9 gm/dl
Platelets count \> 100,000/mm\^3
Aspartate transaminase (AST)/alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN)
Bilirubin ≤ ULN
Patients should have adequate kidney function defined as a serum creatinine \< ULN or calculated creatinine clearance of \> 60ml/min (Cockroft-Gault formula)
Patients should have adequate cardiac function defined as:
No history of acute coronary syndromes (including myocardial infarction, unstable angina, Coronary artery bypass grafting (CABG), coronary angioplasty, or stenting) \< 12 months prior to screening
No impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
Symptomatic chronic heart failure;
Evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities
No uncontrolled arterial hypertension despite appropriate medical therapy (defined as systolic blood pressure \> 160 or diastolic blood pressure \>100)
Electrocardiogram (EKG) showing normal sinus rhythm and a corrected QT (QTc) ≤ 450 ms for male and ≤ 470 ms for female patients
Patients should have adequate pulmonary function defined as:
Lack of uncontrolled pleural effusion requiring recurrent draining procedures (more than once per month)
Lack of oxygen supplementation dependence
All subjects must have the ability to understand and the willingness to sign a written informed consent
Screening 2-dimensional (2-D) echocardiogram (echo) shows a left ventricular ejection fraction (LVEF) \> 40%
Urinalysis shows lack of proteinuria or a maximum of 1+ proteinuria
Women of childbearing potential should use highly effective contraception while receiving the trial regimen and for at least 5 half-lives of M5A-IL2 from the last dose of M5A-IL2
Exclusion
Patients on immunosuppressive treatments including supra-physiological doses of corticosteroids
Patients with history of auto-immune disease including history of inflammatory bowel disease
Patients with active brain metastases
Patients in the child-bearing ages who refuse to use adequate birth control measures (example: contraceptives, barrier method, or abstinence)
Lactating females who do not agree to stop breastfeeding
Known active hepatitis B or C
Major surgical procedure within 4 weeks prior to SBRT
Non-healed wound or surgical incisions
Radiographic evidence of bowel obstruction
Electrolyte disturbances (sodium, potassium, magnesium, calcium, and phosphorous) that are not correctable to at least CTCAE grade 1 with replacement therapy
Known hypersensitivity of any of the study drug agents or components
Patients should not have any uncontrolled illness including ongoing or active infection
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents
Pregnant women are excluded from this study because the investigational agents on this study are highly likely to exert teratogenic or abortifacient effects
Patients with other active malignancies are ineligible for this study
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
What this trial measures
- Maximum tolerated dose (MTD) of the M5A-IL2 immunocytokine (M5A-ICK)At the end of cycle 1 (each cycle is 28 days)
Will be assessed following accelerated titration design 3, single patient cohorts will be used with dose doubling between cohorts until either a dose limiting toxicity (DLT) is observed, or 2 patients experience a moderate (grade 2) M5A-ICK related adverse event. At dose level 5, the design reverts to 3 patient cohorts (following the traditional 3+3 design) with 40% increments between dose levels. In the traditional 3+3 design, once 3 patients at a dose level are evaluable, if none has experienced a DLT, the dose can be escalated.
- Recommended phase 2 doseAt the end of cycle 1 (each cycle is 28 days)
Will either be the MTD, or below, based on the full consideration of late adverse events, sub-DLT toxicities, clinical activity, and biological correlatives.