Trial Search Results

A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.

This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

MedImmune LLC

Intervention(s):

  • Biological: MEDI4276

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   1. Age ≥ 18 years.

   2. Histologically or cytologically documented unresectable, locally advanced or
   metastatic breast cancer or gastric cancer refractory to standard therapy.

      1. For subjects with breast cancer:

         - Prior treatment with trastuzumab, pertuzumab, and T-DM1, either alone or in
         combination, is required.

         - Subjects with a primary tumor that is hormone (estrogen, progesterone, or
         both) receptor-positive or receptor-negative are eligible.

         - Prior hormone therapy is allowed, but last dose must be at least 14 days
         prior to first dose of MEDI4276.

      2. For subjects with gastric cancer:

         - Prior treatment with a trastuzumab containing chemotherapy regimen is
         required.

   3. HER2 Positive disease documented as FISH-positive and/or 3+ by IHC on previously
   collected tumor tissue.

   4. At least one lesion measurable by RECIST Version 1.1.

Exclusion Criteria:

   1. Receipt of any conventional or investigational anticancer treatment within 28 days
   prior to the first dose of MEDI4276.

   2. History of exposure to the following cumulative doses of anthracyclines:

      1. Doxorubicin or liposomal doxorubicin >350 mg/m².

      2. Epirubicin >530 mg/m².

      3. Mitoxantrone >90 mg/m² and idarubicin > 70 mg/m².

      4. If another anthracycline or more than 1 anthracycline has been used, then the
      cumulative dose must not exceed the equivalent of 350 mg/m² of doxorubicin.

   3. Known brain metastases that are untreated, symptomatic, or require therapy to control
   symptoms; or any radiation, surgery or other therapy to control symptoms from brain
   metastases within 2 months prior to first dose of MEDI4276.

Ages Eligible for Study

18 Years - 99 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting