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1

XmAb808 <span class="highlight">Bispecific</span> Antibody with Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of XmAb808, an experimental <span class="highlight">bispecific</span> antibody, with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) 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">XmAb808</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb808 is an experimental immunotherapy called a <span class="highlight">bispecific</span> antibody.</li> <li class="seamTextUnorderedListItem">A <span class="highlight">bispecific</span> antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">XmAb808 is a <span class="highlight">bispecific</span> antibody that targets B7-H3 and CD28.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</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/NCT05585034' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://xencor.com/pipeline/' target='_blank'>Xencor Drug Information Page: XmAb808</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
1

XmAb808 <span class="highlight">Bispecific</span> Antibody with Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors
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Nearest Location:
336 miles
UCLA Hematology/Oncology
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05585034

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Phase I

2

GEN1047 for Stage III or Stage IV Breast Cancer

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of GEN1047, an experimental immunotherapy.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) breast cancer who have progressed after or during at least one prior therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GEN1047, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GEN1047 is a <span class="highlight">bispecific</span> antibody that helps T cells kill cancer cells.</li> <li class="seamTextUnorderedListItem">A <span class="highlight">bispecific</span> antibody binds to two distinct targets and may work better than traditional antibody drugs.</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/NCT05180474' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genmab.com/pipeline/' target='_blank'>Genmab: GEN1047</a> </li></ul>
2

GEN1047 for Stage III or Stage IV Breast Cancer

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors
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Nearest Location:
339 miles
UCLA Department of Medicine Hematology Oncology
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05180474

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Phase I-II

3

Navicixizumab Targeted Therapy for Advanced Triple Negative Breast Cancer

A Phase 2, Multicenter, Open-Label Basket Study of Navicixizumab Monotherapy or in Combination With Paclitaxel or Irinotecan in Patients With Select Advanced Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of navicixizumab, an experimental targeted therapy, alone or with chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that have received 2-4 lines of therapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Navicixizumab, every 2 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Navicixizumab, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Daily blood pressure measurements</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">ECG tests</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Navicixizumab is an experimental targeted therapy called a <span class="highlight">bispecific</span> antibody.</li> <li class="seamTextUnorderedListItem">A <span class="highlight">bispecific</span> antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Navicixizumab targets both DLL4 and VEGF.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">An electrocardiogram (ECG) test records electrical signals in your heart.</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/NCT05453825' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncxerna.com/programs/' target='_blank'>OncXerna Theraputics Drug Information Page: Navicixizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>
3

Navicixizumab Targeted Therapy for Advanced Triple Negative Breast Cancer

A Phase 2, Multicenter, Open-Label Basket Study of Navicixizumab Monotherapy or in Combination With Paclitaxel or Irinotecan in Patients With Select Advanced Solid Tumors
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Nearest Location:
348 miles
Keck Medicine of USC
Los Angeles, CA

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT05453825

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Phase II

4

RO7247669 <span class="highlight">Bispecific</span> Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, PD-L1 Positive Breast Cancer

A Phase II, Multicenter, Randomized, Double-Blind Study of RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of RO7247669, an experimental targeted therapy, with nab-paclitaxel (Abraxane®) chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer that is PD-L1 positive. You must have not yet received treatment for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7247669, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7247669 is an experimental targeted therapy called a <span class="highlight">bispecific</span> antibody.</li> <li class="seamTextUnorderedListItem">A <span class="highlight">bispecific</span> antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">RO7247669 is a <span class="highlight">bispecific</span> antibody that targets PD-1 (programmed death-1) and LAG-3 (lymphocyte-activation gene 3).</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</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/NCT05852691' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tobemstomig' target='_blank'>National Cancer Institute: Tobemstomig (RO7247669)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-Paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
4

RO7247669 <span class="highlight">Bispecific</span> Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, PD-L1 Positive Breast Cancer

A Phase II, Multicenter, Randomized, Double-Blind Study of RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
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Nearest Location:
366 miles
Cancer Blood and Specialty Clinic
Los Alamitos, CA

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT05852691

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Phase II

5

NM32-2668 Trispecific Antibody for Advanced ROR Expressing Breast Cancer

A Phase 1 Study of NM32-2668 (Anti-ROR1/CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients With Selected Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of NM32-2668, an experimental trispecific antibody.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) ROR expressing 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">NM32-2668</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NM32-2668 is an experimental immunotherapy called a trispecific antibody.</li> <li class="seamTextUnorderedListItem">A trispecific antibody binds to 3 distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">NM32-2668 is a <span class="highlight">bispecific</span> antibody that targets ROR1, CD3, and HSA.</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/NCT06299163' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://numab.com/pipeline/' target='_blank'>Numab Therapeutics: NM32-2668 Drug Information Page</a> </li></ul>
5

NM32-2668 Trispecific Antibody for Advanced ROR Expressing Breast Cancer

A Phase 1 Study of NM32-2668 (Anti-ROR1/CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients With Selected Advanced Solid Tumors
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Nearest Location:
1478 miles
Mary Crowley Cancer Research
Dallas, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06299163

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Phase I

6

IMM2902 <span class="highlight">Bispecific</span> Antibody for Advanced HER2 Positive or HER2 Low Breast Cancer

A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients With HER2-Expressing Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of IMM2902, an experimental targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received at least 2 lines of therapy. You must have at least 1 tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMM2902, by IV, weekly for 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMM2902 is an experimental targeted therapy called a <span class="highlight">bispecific</span> antibody.</li> <li class="seamTextUnorderedListItem">A <span class="highlight">bispecific</span> antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">IMM2902 is a <span class="highlight">bispecific</span> antibody that targets HER2 and CD47.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</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/NCT05076591' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.immuneonco.com/display.php?id=120' target='_blank'>ImmuneOnco Biopharmaceuticals Press Release: IMM2902</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li></ul>
6

IMM2902 <span class="highlight">Bispecific</span> Antibody for Advanced HER2 Positive or HER2 Low Breast Cancer

A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients With HER2-Expressing Advanced Solid Tumors
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Nearest Location:
1479 miles
Mary Crowley Cancer Research
Dallas, TX

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Visits:
1 visit every week for 1 year

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ClinicalTrials.gov: NCT05076591

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Phase I

7

A T-Cell Immunotherapy (HER2 BATs) and Keytruda for Women With Metastatic Breast Cancer

A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer

Purpose: To investigate the safety and effects (good and bad) of combining the PD-1 inhibitor Keytruda with an immunotherapy made from your T-cells.

Who is this for?: Women with metastatic (stage IV) breast cancer. You must have had two or more prior therapies (chemotherapy or hormonal) for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once during week 7</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, twice, during week 3-4 and week 7</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, three times, before BATs, during week 3-4 and week 7</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. May require hospitalization</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">HER2 <span class="highlight">bispecific</span> antibody armed T cells (BATs) are an experimental type of T-cell immunotherapy. </li> <li class="seamTextUnorderedListItem">The HER2 BATs will be made by collecting white blood cells from your body. Your white blood cells will then be modified in a lab so they can identify and attack cancer cells. These modified cells will then be infused back into your body.</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/NCT03272334' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/her2bi-armed-activated-t-cells' target='_blank'>NCI Drug Dictionary: HER2Bi-armed ATCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4839366/' target='_blank'>OncoImmunology: HER2 BATs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwt-L2BRA_EiwAacX32ZWZ-hf-RSddVt1Y8_oFJEJzejiyhC9eCFhl1JG4WlqWBf2Aq3rrXhoCf7AQA' target='_blank'>Merck Oncology Drug Information Page: Keytruda®</a> </li></ul>
7

A T-Cell Immunotherapy (HER2 BATs) and Keytruda for Women With Metastatic Breast Cancer

A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer
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Nearest Location:
2376 miles
Ashley Donihee
Charlottesville, VA

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Visits:
1-2 visits a week for 7 weeks, may require hospitalization

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ClinicalTrials.gov: NCT03272334

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Phase I-II

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