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KTN3379

Phase 1

Advanced Cancer | Monoclonal antibody | Oncology |Celldex Therapeutics, Inc.|Last Updated: Jul 24, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02014909A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced TumorsPHASE1 COMPLETED 64Jan 1, 2014Jun 5, 2017Jul 24, 20175 United States
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Study Endpoints
Primary Endpoints
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
Area Under the Concentration-Time Curve (AUC 0 through end of study)
Prior to the initial dose on day 1 through duration of treatment, an expected average of 3 cycles/9 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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
KTN3379BIOLOGICALSingle agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Major Inclusion Criteria: * Part I Histologically- or cytologically-confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exist. Part II Arm A have head and neck cancer or K-Ras wild type EGFR expressing colon cancer, Arm B, have non small cell lun...

Countries:United States
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