Safety Study of VM206RY in Subjects With Expression of HER2 in Breast Cancer

Reyon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Biological: VM206Ad; Biological: VM206DNA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01895491

VM206RY-VM01

Details and patient eligibility

About

The main objective of this study is to evaluate the safety of VM206RY in subjects with expression of HER2 in breast cancer.

Enrollment: 9 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women, 20 years of age

• Stage 3 or 4 breast cancer

• Unresectable breast cancer with Expression of Her2 and one of the following criteria including

  • Prior use of Her2-targeted therapies(Herceptin, Tykerb, taxane and capecitabine) but it was not responding, with Immunohistochemistry (IHC) 3+, or IHC 2+ and FISH+, or SISH+
  • Patients received treatment that three times continuously Different chemotherapies but it was not responding, with Immunohistochemistry (IHC) 2+ and FISH- or SISH-, or Immunohistochemistry (IHC) 1+
  • Prior use of six chemotherapies(Anthracycline, Taxane, Gemcitabine, Capecitabine, Vinorelbine, Cyclophosphamide) but it was not responding, with Immunohistochemistry (IHC) 2+ and FISH or SISH-, or Immunohistochemistry (IHC) 1+

• One or more measurable(or assessable) lesion of breast or metastatic site

  • Spiral CT: ≥ 10mm diameter
  • general measurement methods (CT, X-ray, MRI): ≥ 20mm diameter

• Life expectancy 6 months

• Signed informed consent

Exclusion criteria

• Prior use of breast cancer vaccine

• Active or history of cardiovascular diseases within the past 3 months: Active uncontrolled cardiac disease, including cardiomyopathy, CHF(NYHA Class III~IV), and unstable angina, family history of congenital long QT syndrome or QT/QTc interval >0.45 sec or torsade de points(TdP), and history of idiopathic ventricular tachycardia or ventricular fibrillation, LVEF < 50%

• Patients with coronary artery disease (myocardial infarction, angina, etc.) or a history of coronary artery disease

• Patients who is required hospitalization by severe fever or required antibiotic treatment by serious infection

• Patients who is confirmed as CNS metastases. (Only, patient with stable brain metastases is permit. Among the patients who have not any symptom, do not see the progression before registered the last 2 month)

• History of prior malignancies other than breast cancer within the past 5 years

• Patients with an existing condition or a history of autoimmune disease or immunodeficiency disease

• ECOG score ≥ 3

• Patients with severe dysfunction in major organs

  • Blood: WBC < 3,000/㎕; Platelet < 100,000/㎕; Hematocrit < 30
  • Liver: Total bilirubin ≥ 1.5 x ULN; ALT/AST ≥ 2.5 x ULN
  • Kidney: Creatinine ≥ 1.5 x ULN

• Abnormal values of anti-nuclear Ab, anti-double-stranded DNA and C3, as judged by the investigator

• History of surgical procedure, chemotherapy, Herceptin treatment, corticosteroid therapy, immunosuppressant therapy or radiotherapy within the past 4 weeks

• HIV Ag/Ab, HBs Ag, HCV Ab or HTLV-1 Ab positive

• Psychotropic drug misuse/abuse or alcoholism

• Prior use of vaccine within the past 4 weeks

• Cumulative dose of prior doxorubicin > 360 ㎎/㎡ or epirubicin > 720 ㎎/㎡

• Women who is pregnant or breastfeeding and don't agree to use a contraceptive during the study period.

• Patients who have participated in clinical trials enrolled in this clinical trial within 4 weeks before. (Only patient, who has taken survey and DNA test without drug-treatment, has permit.)

• Patients who are ineligible to participate in this study, as judged by the investigator.

• Patients who prohibit administering GM-CSF and prior use of GM-CSF within the past 4 weeks.

• Patients who expect hypersensitivity to investigational product (VM206RY) or any component of product.

• Due to malignancy neoplasm, patients who require supplementary oxygen or has severe dyspnea at rest

• Patients with hypertension [inadequately controlled hypertension (systolic > 180 mm Hg or diastolic > 100 mm Hg)] or a history of hypertension

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

CohortⅠ

Experimental group

Description:

VM206DNA 6mg and VM206Ad 3\*10\^9VP injected into the brachial muscle

Treatment:

Biological: VM206DNA

Biological: VM206Ad

CohortⅡ

Experimental group

Description:

VM206DNA 12mg and VM206Ad 3\*10\^9VP injected into the brachial muscle

Treatment:

Biological: VM206DNA

Biological: VM206Ad

CohortⅢ

Experimental group

Description:

VM206DNA 24mg and VM206Ad 3\*10\^9VP injected into the brachial muscle

Treatment:

Biological: VM206DNA

Biological: VM206Ad