drugset
drugset / Trial / NCT02561234

A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors

NCT02561234 ↗

Phase 1/2 Completed 98 enrolled Aeglea Biotherapeutics
RandomizedSequentialOpen-labelTreatment

Summary

This is the first-in-human study of the safety of increasing dose levels of AEB1102 in patients with advanced cancers. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and tumor growth.

Timeline

Start
2015-10
Primary completion
2019-05
Completion
2019-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegzilarginase Protein / enzyme biologic 0.01 mg/kg Intravenous
Subject Pegzilarginase Protein / enzyme biologic 0.02 mg/kg Intravenous
Subject Pegzilarginase Protein / enzyme biologic 0.04 mg/kg Intravenous
Subject Pegzilarginase Protein / enzyme biologic 0.08 mg/kg Intravenous
Subject Pegzilarginase Protein / enzyme biologic 0.12 mg/kg Intravenous
Subject Pegzilarginase Protein / enzyme biologic 0.18 mg/kg Intravenous
Subject Pegzilarginase Protein / enzyme biologic 0.27 mg/kg Intravenous
Subject Pegzilarginase Protein / enzyme biologic 0.33 mg/kg Intravenous
Subject Pegzilarginase Protein / enzyme biologic 0.4 mg/kg Intravenous

Indications

No indication recorded.