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Breast CancerPhase 1VM206RYNCT01895491

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

A Phase 1 study testing VM206DNA and VM206Ad in people with Breast Cancer, run by Reyon Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
VM206DNA and VM206Ad
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteSouth Korea
Study dates
Mar 2011to Oct 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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+
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: An Open-Label, Uncontrolled, Single Center, Phase I Trial to Assess the Safety of VM206RY in Subjects With Expression of Her2 in Breast Cancer

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
Being tested
VM206DNA, VM206Ad
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VM206DNABiological

  • VM206AdBiological

Study groups in NCT01895491
Study groupRoleWhat they receive
CohortⅠExperimentalVM206DNA 6mg and VM206Ad 3*10^9VP injected into the brachial muscle
Receives: Biological: VM206DNA; Biological: VM206Ad
CohortⅡExperimentalVM206DNA 12mg and VM206Ad 3*10^9VP injected into the brachial muscle
Receives: Biological: VM206DNA; Biological: VM206Ad
CohortⅢExperimentalVM206DNA 24mg and VM206Ad 3*10^9VP injected into the brachial muscle
Receives: Biological: VM206DNA; Biological: VM206Ad

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 weeks

Secondary outcomes (7)

  1. Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

    DLT was defined as adverse events higher than grade 3 based on NCI CTCAE version 4.0 with respect to their relationship with the study drug and injection procedure until 2 weeks after final injection. MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT.

    Measured: Up to 8 weeks

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

    Measured: Up to 24 weeks

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

    Measured: Up to 24 weeks

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

    Measured: Up to 24 weeks

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

    Measured: Up to 24 weeks

  6. Analysis of GM-CSF level in plasma at pre and post injection using ELISA

    Measured: Up to be confirmed as negative

  7. Analysis of VM206Ad in whole blood at pre and post injection using Q-PCR

    Measured: Up to be confirmed as negative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2013 (estimated)
  2. Study startMar 2011
  3. Primary completionJul 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01895491
Sponsor's protocol ID
VM206RY-VM01
Acronym
VM206RY
Status last verified
Oct 2013
First submitted
12 Jun 2013
Last updated
21 Jan 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VM206DNA and VM206Ad in people with Breast Cancer, run by Reyon Pharmaceutical Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01895491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.

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