V930 First in Man (FIM) Study (V930-002)(COMPLETED)

A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V-930 in Patients With Cancers Expressing HER-2 and/or CEA

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00250419

Enrollment

Registered

2005-11-08

Start date

2005-09-30

Completion date

2008-09-30

Last updated

2015-02-10

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

Conditions

Cancers Expressing HER-2 and/or CEA

Brief summary

To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.

Interventions

BIOLOGICALV930

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 stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer * Patients will either be disease free following primary therapy or have advanced disease with a durable response (\>3 months) after standard therapy * Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis

Exclusion criteria

* Patients with prior treatment with any HER-2 and/or CEA containing vaccine * Patients who have significant cardiac disease * Patients with autoimmune disorders * Patients who are pregnant or lactating

Outcome results

None listed

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