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V930

Phase 1

Cancer | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Aug 4, 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

V930 · 3 trials · 3 indications

Phase 1 3
NCT00647114A 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)Cancer
COMPLETED41 Analytics
NCT00250419V930 First in Man (FIM) Study (V930-002)(COMPLETED)Cancers Expressing HER-2 and/or CEA
COMPLETED26 Analytics
NCT00721461A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)Healthy
COMPLETED24 Analytics
PHASE1COMPLETED
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)
CancerUnlock trial analytics
PHASE1COMPLETED
V930 First in Man (FIM) Study (V930-002)(COMPLETED)
Cancers Expressing HER-2 and/or CEAUnlock trial analytics
PHASE1COMPLETED
A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the safety and tolerability of V930/V932 followed by EP in cancer patients
Week 22
Assess the tolerability of the MedPulser DDS device.
Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation.

Secondary Endpoints

To determine whether V930/V932 can elicit HER-2 specific and CEA specific immune responses measured using an ELISPOT assay
Week 22
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALV930
2EXPERIMENTALV932

Interventions

NameTypeDescription
V930BIOLOGICALV930 - 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.
V932BIOLOGICALV932 - 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).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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 investig...

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Frequently asked questions about V930

What is V930 used for?

V930 is an investigational monoclonal antibody being studied for the treatment of cancers expressing HER-2 and/or carcinoembryonic antigen (CEA). It has been evaluated in Phase 1 clinical trials in patients with these cancers, as well as in healthy volunteers for tolerability studies.

What does V930 target?

V930 targets cancers that express HER-2 and/or carcinoembryonic antigen (CEA). As a monoclonal antibody, it is designed to interact with these cancer-associated markers, though the specific molecular mechanism of action has not been detailed in the available information.

Who is developing V930?

V930 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company has sponsored Phase 1 clinical trials to evaluate the drug's safety and tolerability.

What phase is V930 in?

V930 is in Phase 1 clinical development. All three clinical trials listed for V930 are Phase 1 studies and have been completed. The drug remains investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is V930 in?

V930 has been studied in three completed Phase 1 trials: NCT00250419, a first-in-human study in patients with cancers expressing HER-2 and/or CEA; NCT00647114, a study of V930/V932 in patients with HER-2 and/or CEA-expressing cancers; and NCT00721461, a tolerability study in healthy adults.

Is V930 the same as V932?

V930 and V932 are distinct investigational agents that have been studied together in a clinical trial. The study NCT00647114 evaluated both V930 and V932 in patients with cancers expressing HER-2 and/or CEA, but they are not described as the same drug.