Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)

Phase 1 Terminated 20 enrolled Bayer

NaSingle-groupOpen-labelTreatment

Summary

To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)

Timeline

Start: 2015-03-24
Primary completion: 2016-07-27
Completion: 2016-07-27

Publications

Kim SB, Meric-Bernstam F, Kalyan A, Babich A, Liu R, Tanigawa T, Sommer A, Osada M, Reetz F, Laurent D, Wittemer-Rump S, Berlin J. First-in-Human Phase I Study of Aprutumab Ixadotin, a Fibroblast Growth Factor Receptor 2 Antibody-Drug Conjugate (BAY 1187982) in Patients with Advanced Cancer. Target Oncol. 2019 Oct;14(5):591-601. doi: 10.1007/s11523-019-00670-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aprutumab ixadotin	Unknown	0.1 mg/kg	Intravenous
Subject	Aprutumab ixadotin	Unknown	0.2 mg/kg	Intravenous
Subject	Aprutumab ixadotin	Unknown	0.4 mg/kg	Intravenous
Subject	Aprutumab ixadotin	Unknown	0.8 mg/kg	Intravenous
Subject	Aprutumab ixadotin	Unknown	1.3 mg/kg	Intravenous

Indications

No indication recorded.