Last updated on November 2017

A Phase I Multiple Dose, Dose Escalation Trial of AEB1102 (Co-ArgI-PEG) in Patients With Advanced Solid Tumors


Brief description of study

A Phase I Multiple Dose, Dose Escalation Trial of AEB1102 (Co-ArgI-PEG) in Patients With Advanced Solid Tumors

Detailed Study Description

In this phase I multiple dose, dose escalation study utilizing a classic 3+3 design. Sequential cohorts of patients will receive AEB1102 IV weekly at one of a series of increasing dose levels. Dose escalation will be dependent on the frequency of specific dose-limiting toxicities in the prior cohort of patients. The study will determine the maximum tolerated dose (MTD) of AEB1102, evaluate the safety profile of the compound, assess the pharmacokinetic profile of AEB1102, determine the effect of AEB1102 on blood arginine levels and evaluate the anti-tumor activity of AEB1102.

Following the determination of the MTD, additional cohorts of patients with uveal, cutaneous melanoma and small cell lung cancer will be enrolled and treated with AEB1102 at the MTD.

Clinical Study Identifier: TX15744

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Karl Lewis, MD

University of Colorado
Aurora, CO USA
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Lauren Taiclet

Columbia University
New York, NY USA
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Andy Gnan

University of Pittsburgh
Pittsburgh, PA USA
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Drew Rasco, MD

START
San Antonio, TX USA
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