A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors

Inclusion Criteria

• - Histologically or cytologically confirmed solid tumors that are refractory to standard therapy or for which no standard therapy exist
• - Age ≥ 18 years
• - ECOG Performance Status of 0 or 1
• - LVEF (measured by Echocardiogram) > 50%
• - No gastrointestinal bleeding within 1 year of study entry.
• - Adequate organ and marrow function:
• o Hemoglobin ≥ 10g/dL
• o Absolute Neutrophil Count ≥ 1500/mm3
• o Platelet Count ≥ 100,000/mm3
• o AST & ALT ≤ 2.5 x ULN
• o Bilirubin ≤ 1.5 x ULN
• o Cr Cl ≥ 50 mL/min (as determined by the Cockcroft-Gault equation or by 24-hour urine collection)
• - Prior therapy against VEGF or VEGFRs including, but not limited to bevacizumab, sunitinib, sorafenib, pazopanib, motesanib (AMG706), or cediranib (AZD2171), is permitted so long as the agent does not have any known activity against DLL4 and the last dose received s at least 6 weeks prior to first dose of MEDI0639.
• - Life expectancy ≥ 12 weeks
• - Females of childbearing potential must be surgically sterile, have a sterile male partner, be premenarchal or at least 2 years postmenopausal, practice abstinence or otherwise must use 2 effective methods of contraception from the time of initiation of investigational product.
• - Males, unless surgically sterile, must use 2 effective methods of contraception with a female partner and must agree to continue using such contraception for 90 days after the last dose of MEDI0639