Last updated on September 2017

A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.


Brief description of study

The purpose of this "first-in-human" study of FAZ053 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053 administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult patients with advanced solid tumors. By blocking the interaction between Programmed Death Ligand-1 (PD-L1) and its receptors, Programmed Death-1 (PD-1) and B7.1, FAZ053 inhibits the PD-L1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells. This study has been designed as a Phase I, open-label, multi-center study with a dose escalation part of FAZ053 as single agent and in combination with PDR001, followed by a dose expansion part of FAZ053 as single agent and in combination with PDR001. FAZ053 will initially be dosed every three weeks. A less frequent dosing regimen such as every 6 weeks may be evaluated in parallel. A patient may continue treatment with FAZ053 single agent or in combination with PDR001 until the patient experiences unacceptable toxicity, confirmed disease progression per immune related Response Criteria and/or treatment is discontinued at the discretion of the investigator or the patient.

Clinical Study Identifier: NCT02936102

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Ayca Gucalp

Memorial Sloan-Kettering Cancer Center SC
New York, NY United States
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Filip Janku

UT MD Anderson Cancer Center
Houston, TX United States
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Novartis Pharmaceuticals

Novartis Investigative Site
Toronto, ON Canada
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Novartis Pharmaceuticals

Novartis Investigative Site
Tel Aviv, Israel
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Novartis Pharmaceuticals

Novartis Investigative Site
Koto, Japan
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Novartis Pharmaceuticals

Novartis Investigative Site
Singapore, Singapore
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Novartis Pharmaceuticals

Novartis Investigative Site
Barcelona, Spain
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