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(Last updated: July 07, 2020)

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1

NEAREST SITE: 336 miles
UCLA Hematology & Oncology Clinic
Los Angeles,CA

VISITS: 1 visit every 2-3 weeks

PHASE: I

NCT ID: NCT03219268

MGD013 With or Without Margetuximab for People With HER2 Positive Advanced Breast Cancer

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms Scientific Title

Purpose
To study the safety, effects (good and bad), and best dose of the immunotherapy MGD013 when used alone or in combination with the anti-HER2 targeted therapy margetuximab.
Who is this for?
People with HER2 positive (HER2+) advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options.    Full eligibility criteria
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  • <p class="seamTextPara"> This is a 2-part study. Depending upon which part of the trial is open when you enroll, you will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 1: All solid tumor cancers</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGD013, by IV, every 2-3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 2: HER2 positive cancers only</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGD013, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Margetuximab, by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGD013 is an investigational immunotherapy (only available in clinical trials) called a checkpoint inhibitor.</li> <li class="seamTextUnorderedListItem">MGD013 binds to the checkpoint inhibitors (proteins) PD-1 and LAG3, which helps your immune system go after cancer cells. </li> <li class="seamTextUnorderedListItem">Margetuximab is an investigational anti-HER2 targeted therapy. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced or metastatic solid tumors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03219268' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/792154' target='_blank'>NCI Drug Dictionary: MGD013</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mgd013-pd-1-x-lag-3/' target='_blank'>Macrogenics Drug Information Page: MGD013</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Margetuximab' target='_blank'>Wikipedia: Margetuximab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/immune-checkpoint-inhibitor' target='_blank'>NCI Dictionary of Cancer Terms: Immune Checkpoint Inhibitor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nationalbreastcancer.org/breast-cancer-targeted-therapy' target='_blank'>National Breast Cancer Foundation: Targeted Therapy</a> </li></ul>
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