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1

Immunotherapy and Radiation for Advanced CEA Positive 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

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of M5A-IL2, an experimental immunotherapy, with standard of care stereotactic body radiation therapy (SBRT).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) CEA+ breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (SBRT), 3 sessions within 1 week</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">M5A-IL2 (M5A-ICK), by injection, 3 times within 3 days</li> <li class="seamTextUnorderedListItem">PET/CT scans</li> <li class="seamTextUnorderedListItem">MRI scans and/or bone scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carcinoembryonic Antigen (CEA) is a protein that is present in some cancers, including breast cancer.</li> <li class="seamTextUnorderedListItem">M5A-IL2 (M5A-ICK) is an experimental immunotherapy called an immunocytokine.</li> <li class="seamTextUnorderedListItem">Immunocytokines are small proteins that regulate the activity of immune cells that are important for anti-cancer activity.</li> <li class="seamTextUnorderedListItem">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.</li> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (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.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06130826' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/managing-cancer/treatment-types/immunotherapy/cytokines.html' target='_blank'>American Cancer Society: Cytokines</a> </li></ul>
1

Immunotherapy and Radiation for Advanced CEA Positive 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
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
At least 6 visits within 2 weeks

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ClinicalTrials.gov: NCT06130826

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Phase I

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