A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma

Phase 2 Terminated 30 enrolled Celldex Therapeutics

NaSingle-groupOpen-labelTreatment

Summary

This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.

Timeline

Start: 2018-03-27
Primary completion: 2020-09-16
Completion: 2020-12-16

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision based on emerging risk-benefit profile”

Publications

Duvvuri U, George J, Kim S, Alvarado D, Neumeister VM, Chenna A, Gedrich R, Hawthorne T, LaVallee T, Grandis JR, Bauman JE. Molecular and Clinical Activity of CDX-3379, an Anti-ErbB3 Monoclonal Antibody, in Head and Neck Squamous Cell Carcinoma Patients. Clin Cancer Res. 2019 Oct 1;25(19):5752-5758. doi: 10.1158/1078-0432.CCR-18-3453. Epub 2019 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CDX-3379	Unknown	12 mg/kg	—
Background	Cetuximab	Monoclonal antibody	250 mg/m2	—