Advanced or Relapsed Colorectal Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients who have human leukocyte antigen (HLA)-A*24:02 - Patients with histologically confirmed colorectal cancer (adenocarcinoma) - Patients with advanced or relapsed colorectal cancer who are refractory or intolerant to standard chemotherapy - Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at the time of study enrollment
Exclusion criteria
Exclusion criteria: - Patients who are HIV antibody positive - Patients with an active infection - Patients who have or are suspected to have CNS metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Dose Limiting Toxicity (DLT) Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Safety Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0 efficacy Tumor response Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1 efficacy Immune-response DTH reactions, CTL Measurement, Blood Regulatory T Cell Measurement | — |
Countries
Japan