NCT01227772

Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

A Phase I/IIa Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Active vaccination with tumor specific antigens and VEGFR1 HLA-A24 epitopes can improve survival of patients with advanced Gastric Cancer.

Detailed description

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
BIOLOGICAL	OTSGC-A24	OTSGC-A24 administered at 1 mg in weekly, 2-weekly, and 3-weekly cohorts.

Timeline

• Start date: 2010-11-01
• Primary completion: 2016-11-01
• Completion: 2017-06-01
• First posted: 2010-10-25
• Last updated: 2016-06-22

Locations

3 sites across 3 countries: Japan, Singapore, South Korea