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

NCT01895491 | Completed Phase 1 DMC

• 1 other identifier: VM206RY-VM01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse events (including serious adverse events and adverse events lead to treatment discontinuation) will be described according to severity and to their relationship with the study drug and injection procedure.

  Up to 24 weeks

Secondary Outcomes (7)

• Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

  Up to 8 weeks

• Analysis of HER2 specific antibody formation in plasma at pre and post injection using ELISA or FACS

  Up to 24 weeks

• Analysis of HER2 specific CTL response on PBMC at pre and post injection using IFN-gamma ELISPOT

  Up to 24 weeks

• Assessment of tumor response based on the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)

  Up to 24 weeks

• Change of HER2 level in plasma at pre and post injection using ELISA

  Up to 24 weeks

Study Arms (3)

CohortⅠ

EXPERIMENTAL

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

Biological: VM206DNA; Biological: VM206Ad

CohortⅡ

EXPERIMENTAL

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

Biological: VM206DNA; Biological: VM206Ad

CohortⅢ

EXPERIMENTAL

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

Biological: VM206DNA; Biological: VM206Ad

Interventions

VM206DNA BIOLOGICAL

CohortⅠ; CohortⅡ; CohortⅢ

VM206Ad BIOLOGICAL

CohortⅠ; CohortⅡ; CohortⅢ

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reyon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: July 10, 2013
• Study Start: March 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 21, 2015

Record last verified: 2013-10

Locations

KR (1)