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CV9201

Phase 1

Non Small Cell Lung 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 Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

CV9201 · 1 trial · 1 indication

Phase 1 1
NCT00923312Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)Non Small Cell Lung Cancer
COMPLETED46 Analytics
PHASE1COMPLETED
Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase I: Determination of the recommended dose (RD) for exploration in the phase IIa part of the study
During the first 2-3 month of Phase I
Phase II: Assessment of safety and tolerability of the treatment regimen
Complete duration of Phase II
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CV9201EXPERIMENTALCV9201 is composed of five formulated mRNAs (drug product components) encoding antigens that are overexpressed or exclusively expressed in NSCLC cells.

Interventions

NameTypeDescription
CV9201BIOLOGICALCV9201 is a vaccine consisting of five drug product components. Treatment will be administered on 5 timepoints.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. Male or female and age ≥ 18 yrs and ≤ 75 2. Histologically or cytologically confirmed and documented stage IIIB /IV NSCLC 3. Documented stable disease or objective response according to RECIST criteria after initial chemotherapy or chemo-radiotherapy for advanced, unresectabl...

Countries:GermanySwitzerland
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Non Small Cell Lung Cancer")

Frequently asked questions about CV9201

What is CV9201 used for in Non Small Cell Lung Cancer?

CV9201 is an investigational cancer vaccine being studied for the treatment of Non Small Cell Lung Cancer (NSCLC). It is designed to be used in patients with stage IIIB/IV disease, as evaluated in a completed Phase 1 clinical trial.

Who makes CV9201?

CV9201 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 cancer vaccine for Non Small Cell Lung Cancer.

What phase is CV9201 in?

CV9201 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities and is still undergoing clinical evaluation.

What clinical trials is CV9201 in?

CV9201 has been studied in one completed Phase 1 clinical trial with the identifier NCT00923312. This trial enrolled 46 participants with stage IIIB/IV Non Small Cell Lung Cancer and was conducted in Germany and Switzerland.

Is CV9201 a monoclonal antibody?

CV9201 is classified as a monoclonal antibody modality, though it is described as a cancer vaccine in its clinical trial. It is being investigated for its potential role in treating Non Small Cell Lung Cancer.

Was the CV9201 clinical trial randomized or blinded?

The completed Phase 1 clinical trial of CV9201 was not randomized and was not double-blinded. It was an uncontrolled study, meaning there was no control group, and all enrolled participants received the investigational treatment.