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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 <span class="highlight">bone</span> 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

2

CycloSam <span class="highlight">Bone-Targeting</span> Radioactive Drug for Metastatic Breast Cancer with <span class="highlight">Bone</span> Metastases

A Dose Finding Study of CycloSam® (153-Sm-DOTMP) to Treat Solid Tumor(s) in the <span class="highlight">Bone</span> or Metastatic to the <span class="highlight">Bone</span> (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing's Sarcoma, and Other Solid Tumor(s) to the <span class="highlight">Bone</span> All Eligible)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of CycloSam®, an experimental radioactive drug.

Who is this for?: People with stage IV (metastatic) breast cancer that has spread to the <span class="highlight">bone</span> 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">CycloSam®, by IV, 2 times within 1 week</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CycloSam®, also known as 153-Sm-DOTMP, is an experimental radiation therapy drug called a radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">CycloSam® travels to the <span class="highlight">bone</span> and delivers radiation only to tumors in the <span class="highlight">bone.</li></span> <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/NCT06008483' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://qsambio.com/cyclosam/' target='_blank'>QSAM Biosciences: What is CycloSam®?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/metastatic/bone-metastasis' target='_blank'>Breastcancer.org: Metastasis to the Bone</a> </li></ul>
2

CycloSam <span class="highlight">Bone-Targeting</span> Radioactive Drug for Metastatic Breast Cancer with <span class="highlight">Bone</span> Metastases

A Dose Finding Study of CycloSam® (153-Sm-DOTMP) to Treat Solid Tumor(s) in the <span class="highlight">Bone</span> or Metastatic to the <span class="highlight">Bone</span> (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing's Sarcoma, and Other Solid Tumor(s) to the <span class="highlight">Bone</span> All Eligible)
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Nearest Location:
1634 miles
Clinical Trial Site
Houston, TX

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Visits:
2 visits within 1 week

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ClinicalTrials.gov: NCT06008483

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Phase I

3

Abemaciclib CDK4/6 Inhibitor with Radiation for People with Metastatic HR+, HER2- Breast Cancer with <span class="highlight">Bone</span> Metastases

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer

Purpose: To test different doses of abemaciclib (Verzenio®) CDK4/6 inhibitor to find the best dose in people receiving radiation.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer with <span class="highlight">bone</span> metastases who are planning to receive radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</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/NCT06678269' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

Abemaciclib CDK4/6 Inhibitor with Radiation for People with Metastatic HR+, HER2- Breast Cancer with <span class="highlight">Bone</span> Metastases

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer
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Nearest Location:
2539 miles
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, NJ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06678269

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Phase I

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