Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies

Phase 1/2 Terminated 32 enrolled Symphogen A/S

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is the first study to test Sym013 (Pan-HER) in humans. The primary purpose of this study is to see if Sym013 is safe and effective for patients with advanced epithelial malignancies without available therapeutic options.

Timeline

Start: 2016-11-01
Primary completion: 2019-06
Completion: 2019-06

Outcome

Outcome not reported

Stopped (Business): “Business reasons”

Publications

Berlin J, Tolcher AW, Ding C, Whisenant JG, Horak ID, Wood DL, Nadler PI, Hansen UH, Lantto J, Skartved NJO, Pedersen MW, Patnaik A. First-in-human trial exploring safety, antitumor activity, and pharmacokinetics of Sym013, a recombinant pan-HER antibody mixture, in advanced epithelial malignancies. Invest New Drugs. 2022 Jun;40(3):586-595. doi: 10.1007/s10637-022-01217-7. Epub 2022 Feb 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sym013	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Sym013	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Sym013	Monoclonal antibody	4 mg/kg	Intravenous
Subject	Sym013	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Sym013	Monoclonal antibody	9 mg/kg	Intravenous
Subject	Sym013	Monoclonal antibody	12 mg/kg	Intravenous
Subject	Sym013	Monoclonal antibody	15 mg/kg	Intravenous

Indications

No indication recorded.