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CV9103

Phase 1

Hormonal Refractory Prostate Cancer | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Mar 20, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

CV9103 · 1 trial · 1 indication

Phase 1 1
NCT00831467Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory DiseaseHormonal Refractory Prostate Cancer
COMPLETED48 Analytics
PHASE1COMPLETED
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease
Hormonal Refractory Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Determination of the recommended dose for exploration in the phase II part
6-9 months
Assessment of Safety of trial regimen
2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CV9103EXPERIMENTALCV9103 is applied intradermally into the thigh and upper arm of either side of the body at week 1, week 3, week 7, week 15, week 23

Interventions

NameTypeDescription
CV9103BIOLOGICALOver a period of 23 weeks 5 vaccinations with CV9103 will be administered.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexMALE
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation * Male and age ≥ 18 years (Phase I and II) and ≤ 75 years (Phase II only) * Histologically confirmed diagnosis of adenocarcinoma of the prostate, Gleason Score availab...

Countries:GermanyItaly
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Frequently asked questions about CV9103

What is CV9103 used for?

CV9103 is an investigational monoclonal antibody being developed for the treatment of hormonal refractory prostate cancer. It is currently in Phase 1 clinical development, with one completed trial involving 48 participants. The drug is being studied in patients with this advanced form of prostate cancer.

Who makes CV9103?

CV9103 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical research on this investigational therapy for hormonal refractory prostate cancer.

What phase is CV9103 in?

CV9103 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for hormonal refractory prostate cancer.

What clinical trials is CV9103 in?

CV9103 has one completed clinical trial, registered as NCT00831467. This Phase 1 study, titled "Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease," enrolled 48 male participants aged 18 years and older in Germany and Italy.

Is CV9103 a vaccine or an antibody?

CV9103 is classified as a monoclonal antibody, though its clinical trial title references an RNActive-derived prostate cancer vaccine. The drug is being investigated for hormonal refractory prostate cancer in a Phase 1 study that has been completed.