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A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.
Trial ID: NCT02576548
This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.
A Phase 1/2 Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogencity, and Antitumor Activity of MEDI4276 in Subjects With Select HER2-expressing Advanced Solid Tumors
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
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.
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.
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