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Breast CarcinomaPhase 1NCT06130826

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

A Phase 1 study testing Biopsy, Biospecimen Collection and Bone Scan in people with Breast Carcinoma and Colorectal Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Carcinoma, Colorectal Carcinoma
What is being tested?
Biopsy, Biospecimen Collection and Bone Scan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
27 May 2025to 5 Mar 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Jeffrey Y. Wong, 626-256-4673 ext. 95200, jwong@coh.org

    Jeffrey Y. Wong

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Identify the maximum tolerated dose (MTD) and recommend phase 2 dose (RP2D) and characterize toxicities associated with administration of the M5A-IL2 after fractionated SBRT.

SECONDARY OBJECTIVES:

  1. Describe the therapeutic response to treatment of irradiated and unirradiated tumors per Criteria in Solid Tumors version 1.1 (RECIST v 1.1) guidelines.

II. Describe AEs by M5A-IL2 dose level, per Common Terminology Criteria for Adverse Events [CTCAE] version 5.0.

III. Describe the pharmacokinetics of M5A-IL2. IV. Describe the frequency of auto-antibody formation, overall and by dose of M5A-IL2.

EXPLORATORY OBJECTIVE:

  1. If medically feasible, tumors targeted for SBRT will be biopsied pre-SBRT and 1-2 weeks post 3rd dose of M5A-IL2.

OUTLINE: This is a dose-escalation study of M5A-ICK.

Patients undergo SOC SBRT over 3 fractions on days 1, 3, and 5, followed by M5A-ICK subcutaneously (SC) on days 8, 9, and 10 once daily for a single cycle on study. Patients undergo computed tomography (CT) or positron emission tomography (PET)/CT as well as blood sample collection throughout the trial. Patients may undergo magnetic resonance imaging or bone scan as clinically indicated on the trial. Additionally, patients may optionally undergo tissue biopsy during screening and on study.

After completion of study treatment, patients are followed-up at 3 months.

Being tested
Biopsy, Biospecimen Collection, Bone Scan, Computed Tomography, Immunotherapy
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • ImmunotherapyDrug

    Also called Immunological, Immunological Therapy, Immunologically Directed Therapy

    Receive M5A-IL2 ICK SC

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

Study groups in NCT06130826
Study groupRoleWhat they receive
Treatment (SBRT, M5A-IL2 ICK)ExperimentalPatients undergo SOC SBRT over 3 fractions on days 1, 3, and 5, followed by M5A-ICK SC on days 8, 9, and 10 once daily for a single cycle on study. Patients undergo CT or PET/CT as well as blood sample collection throughout the trial. Patients may undergo magnetic resonance imaging or bone scan as clinically indicated on the trial. Additionally, patients may optionally undergo tissue biopsy during screening and on study.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Immunotherapy; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of the M5A-IL2 immunocytokine (M5A-ICK)

    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.

    Measured: At the end of cycle 1 (each cycle is 28 days)

  2. Recommended phase 2 dose

    Will either be the MTD, or below, based on the full consideration of late adverse events, sub-DLT toxicities, clinical activity, and biological correlatives.

    Measured: At the end of cycle 1 (each cycle is 28 days)

Secondary outcomes (4)

  1. Therapeutic response to treatment

    Will be reported according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    Measured: Up to 2 years

  2. Incidence of adverse events

    All adverse events, including allergic reactions, hypertension, hypotension, and infusion reactions will be summarized in terms of dose level, type and frequency, data of onset and duration (where relevant) using Common Terminology Criteria for Adverse Events [CTCAE] version 5.0.

    Measured: Up to 3 months after last M5A-ICK injection

  3. Number of participants with treatment-related auto-antibody formation

    Frequency of participants with auto-antibody formation, overall and by dose of M5A-IL2.

    Measured: Screening, days 8 and 36, and 3 months

  4. Pharmacokinetics of M5A-IL2 (M5A-ICK blood clearance )

    Blood samples up to 4 days (based on the predicted ICK half life of 10 hours) will be used to determine M5A-ICK blood clearance by ELISA analysis using human CEA for capture and reporting with anti-IL2-HRP.

    Measured: Pre-injection, approximately 1, 4 and 6 hours post injection on each day, and one sample done 1 and 2 days following the 3rd subcutaneous dose of M5A-IL2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start27 May 2025
  3. Primary completion5 Mar 2029 (estimated)
  4. Study completion5 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06130826
Sponsor's protocol ID
20510
Other IDs
NCI-2023-07592, 20510, P30CA033572, R01CA283603
Status last verified
Nov 2026
First submitted
20 Oct 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biopsy, Biospecimen Collection and Bone Scan in people with Breast Carcinoma and Colorectal Carcinoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of the M5A-IL2 immunocytokine (M5A-ICK) (time frame: At the end of cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06130826.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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