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CDX-0158

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

CDX-0158 · 1 trial · 1 indication

Phase 1 1
NCT02642016A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid TumorsAdvanced Cancer
COMPLETED28 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid Tumors
Advanced CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about CDX-0158

What is CDX-0158 used for?

CDX-0158 is an investigational monoclonal antibody being developed for the treatment of advanced cancer. It is intended for adult patients with advanced solid tumors. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes CDX-0158?

CDX-0158 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX. The company is conducting clinical research to evaluate the safety and pharmacokinetics of this investigational therapy.

What phase is CDX-0158 in?

CDX-0158 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the safety and pharmacokinetics of the drug in adult patients with advanced solid tumors. The drug remains investigational and is not yet approved for any use.

What clinical trials is CDX-0158 in?

CDX-0158 has one completed clinical trial, registered under NCT02642016. This Phase 1 study evaluated the safety and pharmacokinetics of CDX-0158 in 28 adult patients with advanced solid tumors in the United States. The trial was uncontrolled and not randomized or blinded.

Is CDX-0158 the same as any other drug?

No alternative names for CDX-0158 have been disclosed. The drug is identified solely by its code name CDX-0158 in clinical trial registrations and development documentation.