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KTN3379

Phase 1

Advanced Cancer | Monoclonal antibody | Oncology |Celldex Therapeutics, Inc.|Last Updated: Aug 1, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

KTN3379 · 3 trials · 3 indications

Phase 1 3
NCT02473731A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer PatientsSquamous Cell Carcinoma of the Head and Neck
COMPLETED12 Analytics
NCT02456701Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379Thyroid Cancer
COMPLETED7 Analytics
NCT02014909A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced TumorsAdvanced Cancer
COMPLETED64 Analytics
PHASE1COMPLETED
A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients
Squamous Cell Carcinoma of the Head and NeckUnlock trial analytics
PHASE1COMPLETED
Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379
Thyroid CancerUnlock trial analytics
PHASE1COMPLETED
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced Tumors
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in pErbB3 levels in tumor tissue
4 weeks

Reduction in pErbB3 levels

The number of patients with BRAF MUT, radioiodine-refractory thyroid cancer in which the combination of vemurafenib and KTN3379 can increase tumoral iodine incorporation to warrant 131I treatment
4 to 6 weeks
Dose limiting toxicities for KTN3379 alone or in combination
Participants will be followed for the duration of treatment, an expected average of 3 cycles/9 weeks

Continued assessment of safety

Secondary Endpoints

Number of patients with adverse events as a measure of safety and tolerability
6 weeks
Ki67 proliferative index in tumor tissue
4 weeks
Changes in tumor measurements (RECIST 1.1 measurements)
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALTreatment with KTN3379 in HPV positive head and neck cancer patients
BEXPERIMENTALTreatment with KTN3379 in HPV negative head and neck cancer patients
Combination of Vemurafenib and KTN3379EXPERIMENTALVemurafenib 960 mg po bid KTN3379 1000 mg IV q2weeks
KTN3379EXPERIMENTALKTN3379
Part II, Arm AEXPERIMENTALCombination of KTN3379 and cetuximab
Part II, Arm BEXPERIMENTALCombination of KTN3379 and erlotinib
Part II, Arm CEXPERIMENTALCombination of KTN3379 and vemurafenib
Part II, Arm DEXPERIMENTALCombination of KTN3379 and trastuzumab

Interventions

NameTypeDescription
KTN3379BIOLOGICAL -
vemurafenibDRUG960 mg po bid
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Histologically or cytologically confirmed primary, untreated SCCHN including variants. Patients must be candidates for surgical resection. Primary tumors of oral cavity, oropharynx, hypopharnyx or larynx are included. 2. Written informed consent and any locally required autho...

Countries:United States
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about KTN3379

What is KTN3379 used for?

KTN3379 is an investigational monoclonal antibody being studied for use in oncology, specifically for advanced cancer, squamous cell carcinoma of the head and neck, and thyroid cancer. It is being developed by Celldex Therapeutics, Inc. (CLDX) and is currently in Phase 1 clinical development.

What does KTN3379 target?

KTN3379 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating certain cancers, including head and neck squamous cell carcinoma and thyroid cancer.

Who makes KTN3379?

KTN3379 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced tumors.

What phase is KTN3379 in?

KTN3379 is in Phase 1 clinical development. All three clinical trials listed for this drug are Phase 1 studies, and they have all been completed. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is KTN3379 in?

KTN3379 has been studied in three completed Phase 1 clinical trials: NCT02014909, a safety and pharmacokinetics study in adults with advanced tumors; NCT02456701, a study combining vemurafenib and KTN3379 in BRAF mutant thyroid cancer; and NCT02473731, a window of opportunity study in surgically resectable head and neck cancer patients.

Is KTN3379 the same as any other drug?

KTN3379 is not known to have any alternative names. It is a distinct investigational monoclonal antibody developed by Celldex Therapeutics, Inc. for potential use in treating certain types of cancer, including head and neck squamous cell carcinoma and thyroid cancer.