Last updated on February 2019

A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 (formerly MGA012) in Patients with Advanced Solid Tumors


Brief description of study

This study is a Phase 1, open-label, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary anti-tumor activity of INCMGA00012 administered IV every two or four weeks in patients with relapsed/refractory, unresectable locally advanced or metastatic solid tumors. 

The study consists of two phases, a Dose Escalation Phase (which has been completed) followed by a Cohort Expansion Phase.

The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.

 

Clinical Study Identifier: TX218019

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