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CDX-0158

Phase 1

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

CDX-0158 target and mechanism

Molecular targetKIT
Target classProtein
ModalityMonoclonal antibody

Also known as CDX-0158 (formerly known as KTN-0158)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

CDX-0158 clinical trials

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 7 trials (matched to "Advanced Cancer")

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Frequently asked questions about CDX-0158

What is CDX-0158?

CDX-0158 is an investigational monoclonal antibody developed by Celldex Therapeutics for advanced cancer. It is a biomarker-selected therapy, meaning patients are screened for a relevant marker before treatment. CDX-0158 has been studied in a single Phase 1 clinical trial and is not an approved medicine.

What is CDX-0158 used for?

CDX-0158 was studied for the treatment of advanced cancer, specifically advanced solid tumors in adults. The research enrolled patients 18 years and older with advanced disease. It remains an investigational agent and has not been approved for any indication.

What does CDX-0158 target?

CDX-0158 targets KIT, a protein receptor also known as CD117. By binding KIT, the monoclonal antibody is designed to interfere with signaling that supports tumor cell growth. KIT is a recognized target in several cancer types, and CDX-0158 was developed as a biomarker-selected therapy directed at this protein.

Who is developing CDX-0158?

CDX-0158 is being developed by Celldex Therapeutics, Inc., which trades on the Nasdaq under the ticker CLDX. The company sponsored the clinical program evaluating the antibody in patients with advanced solid tumors.

What phase is CDX-0158 in?

CDX-0158 is in Phase 1 development. Its only recorded clinical trial, NCT02642016, has been completed, and no trials are currently active. The study was a Phase 1 evaluation of safety and pharmacokinetics in adult patients with advanced solid tumors.

What clinical trials is CDX-0158 in?

CDX-0158 has been evaluated in one clinical trial, NCT02642016, titled a study to evaluate the safety and pharmacokinetics of CDX-0158 in adult patients with advanced solid tumors. The Phase 1 trial was completed, enrolled 28 patients in the United States, and was an uncontrolled, non-randomized study.

Is CDX-0158 the same as KTN-0158?

Yes. CDX-0158 was formerly known as KTN-0158, so the two names refer to the same monoclonal antibody. References to KTN-0158 describe the same investigational KIT-targeted agent now identified as CDX-0158 under Celldex Therapeutics.