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INO-3106, INO-9012

Phase 1

Aerodigestive Precancerous Lesions and Malignancies | Monoclonal antibody | Oncology |Inovio Pharmaceuticals, Inc.|Last Updated: Nov 16, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment3

FDA Designations

No designations recorded

Clinical trial landscape

INO-3106, INO-9012 · 1 trial · 1 indication

Phase 1 1
NCT02241369Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and MalignanciesAerodigestive Precancerous Lesions and Malignancies
COMPLETED3 Analytics
PHASE1COMPLETED
Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies
Aerodigestive Precancerous Lesions and MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events measured and graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
Up to 6 months
Injection site reactions including skin erythema, induration pain and tenderness at administration site
Up to 15 weeks

Secondary Endpoints

HPV6 specific Ig levels
Up to 6 months
Number of antigen-specific IFN-γ-secreting cells in response to stimulation with HPV6 by antigen-specific IFN-γ ELISpot assays
Up to 6 months
Cytotoxic T cells in response to HPV6 specific immunotherapy by flow cytometry
Up to 6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort IEXPERIMENTAL3 mg of INO-3106 (D0); 6 mg of INO-3106 (Wk3); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk6); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk9);
Cohort IIEXPERIMENTAL6 mg of INO-3106 in combination with 1 mg of INO-9012, or at the MTD determined above at D0, Wk3, Wk6, Wk9

Interventions

NameTypeDescription
INO-3106, INO-9012BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Signed and dated written Ethics Committee approved informed consent * Age ≥18 years * Histologically documented HPV-6 positive aerodigestive invasive malignancy (mucosal squamous cell head and neck cancer or lung cancer) who have completed therapies such as radiation/chemoradi...

Countries:United States
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Frequently asked questions about INO-3106, INO-9012

What is INO-3106 used for?

INO-3106 is an investigational immunotherapy being studied for the treatment of aerodigestive precancerous lesions and malignancies associated with HPV-6. It is currently in clinical development and has not been approved by the FDA.

What does INO-3106 target?

INO-3106 is a monoclonal antibody that targets HPV-6, a virus associated with aerodigestive precancerous lesions and malignancies. By targeting this virus, the therapy aims to treat conditions caused by HPV-6 infection.

Who makes INO-3106?

INO-3106 is developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol INO.

What phase is INO-3106 in?

INO-3106 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy.

What clinical trials is INO-3106 in?

INO-3106 has been studied in a Phase 1 clinical trial with the identifier NCT02241369, titled 'Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies'. This trial was completed in the United States with 3 participants.

Is INO-3106 the same as INO-9012?

INO-3106 and INO-9012 are both being developed by Inovio Pharmaceuticals, Inc. They are listed together as a combination therapy for the treatment of aerodigestive precancerous lesions and malignancies.