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(Last updated: July 07, 2020)

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1

NEAREST SITE: 1414 miles
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha,NE

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04306900

TTX-030 in Combination With Chemotherapy or Immunotherapy or Both in Advanced Breast Cancer

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of using TTX-030 (an experimental drug that targets the tumor microenvironment) with either chemotherapy or Budigalimab (a type of immunotherapy) or both chemotherapy and Budigalimab.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TTX-030</li> <li class="seamTextUnorderedListItem">Budigalimab (ABBV-181), by IV</li> <li class="seamTextUnorderedListItem">mFOLFOX6, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TTX-030</li> <li class="seamTextUnorderedListItem">Budigalimab (ABBV-181), by IV</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TTX-030</li> <li class="seamTextUnorderedListItem">mFOLFOX6, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TTX-030</li> <li class="seamTextUnorderedListItem">Budigalimab (ABBV-181), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TTX-030 is an experimental drug that may work by changing the tumor microenvironment (the tissue that surrounds the tumor) and by causing the immune system to go after the tumor. </li> <li class="seamTextUnorderedListItem">Budigalimab (ABBV-181) is an experimental PD-1 inhibitor. PD-1 inhibitors are a type of immunotherapy that get the immune system to see and go after cancer cells.</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) is a chemotherapy commonly used in breast cancer. </li> <li class="seamTextUnorderedListItem">mFOLFOX6 is a chemotherapy regimen that combines three different drugs: leucovorin calcium, fluorouracil, and, oxaliplatin. It is commonly used in colorectal cancer.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04306900' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tizonatx.com/science/' target='_blank'>Drug Company Information Page: TTX-030</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd1-monoclonal-antibody-abbv-181' target='_blank'>NCI Drug Dictionary: Budigalimab (ABBV-181)</a> </li><li class='seamTextUnorderedListItem'><a href='https://abbviescience.com/oncology/pipeline' target='_blank'>Drug Company Information Page: ABBV-181 (Budigalimab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/folfox' target='_blank'>NCI Drug Dictionary: mFOLFOX-6</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/docetaxel.aspx' target='_blank'>Chemocare: Docetaxel</a> </li></ul>
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