drugset

drugset / Trial / NCT01117428

Sym004 in Patients With Advanced Solid Tumors

NCT01117428 ↗

Phase 1/2 Completed 111 enrolled Symphogen A/S

NaSingle-groupOpen-labelTreatment

Summary

This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and consists of five parts.

Timeline

Start: 2010-03
Primary completion: 2015-02
Completion: 2015-05

Publications

Dienstmann R, Patnaik A, Garcia-Carbonero R, Cervantes A, Benavent M, Rosello S, Tops BB, van der Post RS, Argiles G, Skartved NJ, Hansen UH, Hald R, Pedersen MW, Kragh M, Horak ID, Braun S, Van Cutsem E, Tolcher AW, Tabernero J. Safety and Activity of the First-in-Class Sym004 Anti-EGFR Antibody Mixture in Patients with Refractory Colorectal Cancer. Cancer Discov. 2015 Jun;5(6):598-609. doi: 10.1158/2159-8290.CD-14-1432. Epub 2015 May 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sym004	Monoclonal antibody	6 mg/kg	—
Subject	Sym004	Monoclonal antibody	9 mg/kg	—
Subject	Sym004	Monoclonal antibody	12 mg/kg	—
Subject	Sym004	Monoclonal antibody	18 mg/kg	—

Indications