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(Last updated: October 24, 2020)

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1

NEAREST SITE: 752 miles
University of Arizona Cancer Center
Tucson,AZ

VISITS: Weekly for 1 month, then 1 visit every 2 weeks, ongoing

PHASE: I

NCT ID: NCT02627274

RO6874281 Alone or With Trastuzumab For Advanced Breast Cancer

An Open-Label,Multicenter,Dose-Escalation,Phase Ia/Ib Study to Evaluate Safety,Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP),as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C) Scientific Title

Purpose
To test the safety and effects (good and bad) of RO6874281 when it is given alone or with trastuzumab (Herceptin®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer. This study will test the safety and effects (good and bad) of RO6874281 when it is given alone or with trastuzumab (Herceptin®).    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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">RO6874281, by IV, once every week for 1 month, then once every 2 weeks </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO6874281, by IV, once every week for 1 month, then once every 2 weeks </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 2 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Herceptin is a HER2-targeted therapy used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">RO6874281 is an investigational targeted therapy that blocks FAP and IL2a. It stimulates immune cells to go after tumor cells. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients 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/NCT02627274' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-fap-interleukin-2-fusion-protein-ro6874281' target='_blank'>NCI Drug Dictionary: Anti-FAP/interleukin-2 fusion protein RO6874281</a> </li></ul>
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