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

Phase 1/Phase 2
21 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

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.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed inoperable or metastatic
adenocarcinoma of the stomach or lower third of the oesophagus refractory or
intolerable to standard therapy.

- Patients must have measurable or evaluable disease.

- Age >= 201years

- ECOG performance status of 0 to 2

- Life expectancy at least 3 months

- Patients must have normal organ and marrow function as defined below:

- absolute neutrophil count >=1,500/mcL

- platelets >=100,000/mcL

- total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of

- Normal creatinine within normal institutional limits

- Patients must be HLA-A*2402

- Patients must have recover from all reversible treatment toxicity from prior
chemotherapy, radiotherapy or surgery.

- The effects of OTSGC-A24 on the developing human fetus at the recommended therapeutic
dose are unknown. For this reason, women of child-bearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and for the duration of study participation. Should
a woman become pregnant or suspect she is pregnant while participating in this study,
she should inform her treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Patients receiving any other investigational agents.

- History of significant gastrointestinal bleeding that required intervention within
the prior 1 month is ineligible; inherited bleeding diathesis or coagulopathy.

- Serious non healing wound and peptic ulcer disease

- Previous history of intestinal perforation

- Invasive procedures defined as follows (Insertion of a vascular access device is not
considered major/minor surgery):

- Major surgical procedure, open biopsy or significant traumatic injury =28 days prior
to -registration

- Anticipation of need for major surgical procedures during the course of the study

- Core biopsy <=7 days

- Minor surgery <=2 weeks

- Symptomatic CNS metastasis

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg),
symptomatic congestive heart failure, unstable angina pectoris, myocardial
infarction/cerebrovascular event (<=6 months prior to study entry), cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements, long term systemic immunosuppressant or corticosteroid.

- Women who are breast-feeding or pregnant are excluded from this study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety of OTSGC-24

Outcome Description:

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.

Outcome Time Frame:

within 4 weeks of treatment

Safety Issue:


Principal Investigator

Wei Peng Yong, MRCP, MB ChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

November 2010

Completion Date:

November 2014

Related Keywords:

  • Gastric Cancer
  • gastric cancer vaccine
  • OTSGC-A24
  • A Phase I/IIa study
  • HLA-A24-positive
  • Stomach Neoplasms