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V930

Phase 1

Cancer | Monoclonal antibody | Oncology |Merck & Company, Inc.|Trials Updated: Mar 13, 2015

V930 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Nov 2005

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials2
Total Enrollment67

FDA Designations

No designations recorded

V930 clinical trials

V930 · 2 trials · 2 indications

Phase 1 2
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
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

Study Endpoints

Primary Endpoints

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

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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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about V930

What is V930?

V930 is an investigational monoclonal antibody developed by Merck & Company, Inc. (MRK) for oncology. It is being studied in patients with cancers that express HER-2 and/or CEA, which are biomarkers used to select patients for treatment. V930 remains in Phase 1 clinical development and is not approved for any use.

What is V930 used for in cancer?

V930 is being studied for the treatment of cancers expressing HER-2 and/or CEA. These biomarkers are used to select patients whose tumors carry one or both of these targets. The program is in Phase 1 testing, so V930 is investigational and has no approved indication.

Who makes V930?

V930 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program studying V930 in biomarker-selected cancer patients.

What phase is V930 in?

V930 is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 1 program has been completed, with no active trials currently listed.

What clinical trials is V930 in?

V930 has been studied in two completed Phase 1 trials. NCT00250419 was the first-in-man study in cancers expressing HER-2 and/or CEA, enrolling 26 patients. NCT00647114 tested V930/V932 in patients with cancers expressing HER-2 and/or CEA and enrolled 41 patients.