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CDX-0158

Phase 1

Advanced Cancer | Monoclonal antibody | Oncology |Celldex Therapeutics, Inc.|Last Updated: Jun 12, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02642016A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid TumorsPHASE1 COMPLETED 28Dec 1, 2015Jun 4, 2019Jun 12, 20194 United States
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Study Endpoints
Primary Endpoints
Dose limiting toxicities for CDX-0158
Participants will be evaluated for DLTs from the first adminstration of CDX-0158 through 21 days following initial dosing.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CDX-0158EXPERIMENTAL -
Interventions
NameTypeDescription
CDX-0158 (formerly known as KTN-0158)BIOLOGICALSingle agent CDX-0158 until unacceptable toxicity or progressive disease
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Written informed consent and any locally required authorization (eg, HIPAA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. 2. Metastatic or unresectable cancer that expresses KIT as document...

Countries:United States
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