A Study to Test V930/V932 in Patients With Cancers Expressing Human Epidermal Growth Factor Receptor 2 (HER-2) and/or Carcinoembryonic Antigen (CEA)(V930-003)(COMPLETED)

A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V930/V932 in Patients With Cancer Expressing HER-2 and/or CEA

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00647114

Enrollment

Registered

2008-03-31

Start date

2007-08-31

Completion date

2009-04-30

Last updated

2015-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancers expressing HER-2 and/or CEA

Brief summary

Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.

Detailed description

The optional followup period for this study is 1 year after the last vaccination.

Interventions

BIOLOGICALV930

V930 - Over a 94 week duration, patients will receive a series of 5 injections (2.5 mg/injection), one every other week. Within 2 minutes of each injection of V930, each patient will be given an EP-IM injection consisting of two 60 msec pulses.

BIOLOGICALV932

V932 - Over a 94 week duration, patients will receive a series of 5 injections, 6 patients will initially received intramuscular V932 vaccinations at a low dose (0.5x109 vg/injection),and following a safety assessment, up to an additional 35 patients will be treated with the high dose V932 (0.5x1011 vg/injection).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients must have completed surgical treatment for his/her primary disease at least 1 month prior to enrollment * Patient must not be pregnant 3 days prior to enrollment

Exclusion criteria

* Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent * Patient has had their spleen removed or has a history of autoimmune disorders * Patient is a regular user of any illicit drugs or has used within the past year of drug or alcohol abuse * Patient is pregnant or breastfeeding or is expecting to conceive anytime following the study * Patient is known to be Human Immunodeficiency Virus (HIV)-seropositive * Patient has a known history of Hepatitis B or C * Patient has received a vaccine for any disease or condition within one month of enrollment * Patient has a primary central nervous system tumor.

Design outcomes

Primary

Measure	Time frame
To determine the safety and tolerability of V930/V932 followed by EP in cancer patients	Week 22

Secondary

Measure	Time frame
To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay	Week 22

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026