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ICT-107

Phase 2

Glioblastoma Multiforme | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Mar 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

ICT-107 · 1 trial · 1 indication

Phase 2 1
NCT01280552A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)Glioblastoma Multiforme
COMPLETED124 Analytics
PHASE2COMPLETED
A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
Glioblastoma MultiformeUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival (OS)
2 -3 years

The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis

Overall Survival in HLA-A2 Patients
2-3 years

Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.

Secondary Endpoints

PFS
2-3 years
Progression Free Survival in HLA- A2 Patients
2-3 yers
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ICT-107EXPERIMENTALAutologous dendritic cells pulsed with immunogenic peptides from tumor antigens
ControlPLACEBO_COMPARATORAutologous dendritic cells that have not been pulsed with antigens

Interventions

NameTypeDescription
ICT-107BIOLOGICALAutologous dendritic cells pulsed with immunogenic antigens
Placebo DCBIOLOGICALAutologous dendritic cells (DC) that have not been pulsed with antigens
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: 1. Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and not yet received chemoradiation. 2. ≥ 18 years of age 3. HLA-A1 or HLA-A2 positive 4. KPS score of ≥ 70% 5. Baseline hematologic studies and chemistry profiles must meet the following criteria:...

Countries:United States
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Frequently asked questions about ICT-107

What is ICT-107 used for?

ICT-107 is an investigational immunotherapy being studied for the treatment of Glioblastoma Multiforme (GBM), a type of brain cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does ICT-107 target?

ICT-107 is a monoclonal antibody designed to target tumor-associated antigens in Glioblastoma Multiforme. It is being developed as an immunotherapy to stimulate the patient's immune system against cancer cells.

Who makes ICT-107?

ICT-107 is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DTIL.

What phase is ICT-107 in?

ICT-107 is currently in Phase 2 clinical development. It has completed one Phase 2 trial and is not yet approved for commercial use.

What clinical trials is ICT-107 in?

ICT-107 has been studied in a Phase 2 clinical trial with the identifier NCT01280552. This trial, titled 'A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)', was completed and enrolled 124 participants in the United States.

Is ICT-107 the same as other names?

ICT-107 is the primary name for this investigational drug. No alternative names have been reported for this asset.