EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors

Inclusion criteria

• Male and female subjects ≥18 years of age
• Signed written informed consent
• Histologically or cytologically documented metastatic or locally advanced survivin-expressing solid tumor for which no established therapy exists
• Disease must be measurable by RECIST criteria or evaluable by clinical, radiographic, or laboratory criteria established for the given tumor entity
• Expressing at least one of the following HLA alleles:HLA-A1,-A2,-A3,-A24, and -B7 assessed by HLAgenotyping
• ECOG performance status of ≤1, estimated life expectancy of at least 3 months
• Adequate hematological function defined by WBC ≥3 x 10x9/L, lymphocyte count ≥0.5 x 10x9/L, hemoglobin ≥10 g/dL, platelet count ≥100 x 10x9/L
• Adequate blood coagulation parameters defined as aPTT and INR ≤ 1.5 x ULN
• Adequate renal function defined by a serum creatinine ≤2 x ULN
• Adequate hepatic function defined by total bilirubin ≤2 x ULN and AST and ALT levels ≤2.5 x ULN (in subjects with liver metastases ≤5 x ULN)
• Effective contraception for female and male subjects if the risk of conception exists

Exclusion criteria

• Treatment in another clinical study within the past 30 days prior to the first administration of study treatment
• Previous treatment with an investigational anticancer vaccine
• Requirement of concurrent treatment with a nonpermitted drug
• Active significant autoimmune disease (with the exception of vitiligo)
• Receipt of allogeneic stem cell transplantation
• Significant acute or chronic infections (e.g. viral hepatitis, HIV)
• Primary brain tumors and brain metastases (with the exception of brain metastases that are stable after irradiation or surgically resected brain metastases if subjects have been asymptomatic for ≥6 months)
• Rapidly progressive disease (e.g. tumor lysis syndrome)
• Radiotherapy, chemotherapy, surgery (excluding prior diagnostic biopsy), immunotherapy or any investigational drug within 30 days before the start of study treatment
• Pregnancy or lactation
• Active drug or alcohol abuse
• Known hypersensitivity to the study treatment or any of its components
• Any significant disease that, in the Investigator's opinion, should exclude the subject from the study; for questions about this criterion, the Investigator should contact the sponsor.
• Persisting toxicity related to prior therapy ≥grade 2 National Cancer Institute-Common Terminology Criteria For Adverse Events version 3.0
• Legal incapacity or limited legal capacity