Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

Phase 1 Completed 44 enrolled Merrimack Pharmaceuticals Sanofi · collab

NaSingle-groupOpen-labelTreatment

Summary

This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design to determine maximum tolerated dose/recommended Phase 2 dose.

Timeline

Start: 2008-07
Primary completion: 2010-05
Completion: 2013-09

Publications

Denlinger CS, Keedy VL, Moyo V, MacBeath G, Shapiro GI. Phase 1 dose escalation study of seribantumab (MM-121), an anti-HER3 monoclonal antibody, in patients with advanced solid tumors. Invest New Drugs. 2021 Dec;39(6):1604-1612. doi: 10.1007/s10637-021-01145-y. Epub 2021 Jul 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seribantumab	Monoclonal antibody	3.2 mg/kg	Intravenous
Subject	Seribantumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Seribantumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Seribantumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Seribantumab	Monoclonal antibody	20 mg/kg	Intravenous

Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

Summary

Timeline

Publications

Drugs

Indications