A Phase I, Open-label, Multi-centre Dose Escalation Study of FAZ053 as Single Agent and in Combination With PDR001 in Adult Patients With Advanced Malignancies
The purpose of this "first-in-human" study of FAZ053 is to characterize the safety,
tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumour activity of FAZ053
administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult
patients with advanced solid tumours.
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 antitumour immune response by activating effector T-cells and inhibiting
This study has been designed as a Phase I, open-label, multi-centre 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.
View this trial on ClinicalTrials.gov
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