A Phase I/IIa Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer
Although palliative chemotherapy improved the outcome of patients with advanced Gastric
Cancer, the prognosis for this group of patients remains poor. Tumor specific antigens and
angiogenesis pathway are potential targets for immunotherapy. A cocktail of peptide vaccines
is selected to overcome gastric cancer's heterogeneous and enhance the anti-tumor effect.
Five HLA-A*2402-binding peptide vaccines derived from tumor specific antigens and VEGFR1 are
chosen based on the frequencies of their expressions in gastric cancer and the ability to
induce specific cytotoxic T-lymphocytes. In preclinical model, both down regulation these
targets with siRNA and active vaccination resulted in tumor regression. The purpose of the
study is to evaluate the safety and optimal dosing schedule of a cancer vaccine cocktail,
OTSGC-A24 targeting novel specific tumor antigens FOXM1, DEPDC1, KIF20A, URLC10 and VEGFR1
in advanced gastric cancer patients with HLA-2402 haplotype.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety of OTSGC-24
Dose limiting toxicity will be evaluated during the first 4 weeks of treatment. If in the unlikely event that DLT is observed in 1 of the 3 subjects, an additional 3 subjects will be enrolled at the same dose level. If DLT is observed in 2 of the 6 subjects, subsequent cohorts will be treated at 0.5 mg.
within 4 weeks of treatment
Wei Peng Yong, MRCP, MB ChB
National University Hospital, Singapore
Singapore: Domain Specific Review Boards