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

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.
• a. 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.
• b. 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.