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1

<span class="highlight">NKT3964</span> Targeted Therapy for Advanced HR+, HER2- Breast Cancer

A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader <span class="highlight">NKT3964</span> in Adults With Advanced/Metastatic Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of <span class="highlight">NKT3964,</span> an experimental CDK2 PROTAC degrader.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have no standard treatment options available. You must have received 0-1 line of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">NKT3964,</span> by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKT3964 is an experimental targeted therapy called a CDK2 PROTAC degrader that breaks down CDK2 to slow or stop cancer cells from growing.</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/NCT06586957' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nikangtx.com/science-and-pipeline/' target='_blank'>NiKang Therapeutics: NKT3964 Drug Information Page</a> </li></ul>
1

<span class="highlight">NKT3964</span> Targeted Therapy for Advanced HR+, HER2- Breast Cancer

A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader <span class="highlight">NKT3964</span> in Adults With Advanced/Metastatic Solid Tumors
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Nearest Location:
590 miles
Intermountain Health
Salt Lake City, UT

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06586957

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Phase I

2

Studying Immune Cells in Women with Stage I-IV Breast Cancer

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Purpose: To study immune cells involved in breast cancer.

Who is this for?: Women with stage I, stage II, or stage III breast cancer who have not yet received surgery, or women with stage IV (metastatic) breast cancer. You must be receiving care at the Ohio State Comprehensive Cancer Center or Stefanie Spielman Comprehensive Breast Center. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood sample</li> <li class="seamTextUnorderedListItem">Tumor and/or lymph node samples (if removed during surgery)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Natural killer <span class="highlight">(NK)</span> cells are immune cells that identify and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Myeloid derived suppressor cells (MDSC) are immune cells that kill <span class="highlight">NK</span> cells, which helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">In this study, researchers will look for and study these types of immune cells in the blood, tumor, and/or lymph node samples.</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/NCT04022616' target='_blank'>ClinicalTrials.gov</a> </li></ul>
2

Studying Immune Cells in Women with Stage I-IV Breast Cancer

Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
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Nearest Location:
2108 miles
Ohio State University Comprehensive Cancer Center
Columbus, OH

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Visits:
At least 1 visit

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ClinicalTrials.gov: NCT04022616

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Phase NA

3

Gemcitabine Chemotherapy and <span class="highlight">NK</span> Cell Therapy for Metastatic HER2 Negative Breast Cancer

Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer <span class="highlight">(NK)</span> Cells in Advanced GD2-expressing Breast Cancers (DiG <span class="highlight">NKs)</span>

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of gemcitabine (Gemzar®) chemotherapy and <span class="highlight">NK</span> cell therapy with or without naxitamab (Danyelza®) targeted therapy.

Who is this for?: People with stage IV (metastatic) HER2 negative (HER2-) breast cancer who have received at least 1 line of therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi <span class="highlight">NK</span> cell therapy, by IV, monthly, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi <span class="highlight">NK</span> cell therapy, by IV, 2 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi <span class="highlight">NK</span> cell therapy, by IV, monthly, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi <span class="highlight">NK</span> cell therapy, by IV, 2 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy drug that blocks cancer cells from making DNA which may kill cancer cells.</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®) is a type of targeted therapy called a GD2 inhibitor. GD2 inhibitors help your immune system attack tumor cells.</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®) is approved to treat people with other types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">TGFBi <span class="highlight">NK</span> cell therapy is an experimental immunotherapy. <span class="highlight">NK</span> cells are part of your natural immune system and can identify cancer cells and help your immune system kill cancer cells.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</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/NCT06026657' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/gemzar' target='_blank'>Breastcancer.org: Gemcitabine (Gemzar®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a621005.html#:~:text=Naxitamab%2Dgqgk%20injection%20is%20used,have%20responded%20to%20other%20treatments.' target='_blank'>Medline Plus: Naxitamab (Danyelza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/body/24898-natural-killer-cells' target='_blank'>Cleveland Clinic: NK Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>
3

Gemcitabine Chemotherapy and <span class="highlight">NK</span> Cell Therapy for Metastatic HER2 Negative Breast Cancer

Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer <span class="highlight">(NK)</span> Cells in Advanced GD2-expressing Breast Cancers (DiG <span class="highlight">NKs)</span>
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Nearest Location:
2108 miles
Ohio State University Comprehensive Cancer Center
Columbus, OH

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Visits:
May require hospitalization; 4-7 visits every month

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ClinicalTrials.gov: NCT06026657

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Phase I-II

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