Advanced solid malignancies
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Histologically or cytologically confirmed solid malignancies - HLA-A*2402 - Advanced cancer patient who is refractory to standard therapy or no established treatment exists
Exclusion criteria
Exclusion criteria: - Concomitant infection requiring systemic administration of antibiotics or antiviral drugs - Positive for either HIV antibody, HBs antigen or HCV antibody testing within 90 days before entry - Brain metastasis which is symptomatic or requiring treatment, excluding primary malignant brain tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Safety CTCAE ver4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Tumor response, Biomarkers Tumor response: RECIST Biomarkers: DTH, CTL induction, anti WT1 antibody etc | — |
Countries
Japan