Stopped: The early termination was based on a business decision that FAZ053 would no longer be formulated and was not a consequence of any safety concern.
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. 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.
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Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: throughout the study and up to 150 days after end of treatment (up to approximately 46 months)
Incidence of Dose Limiting Toxicities (DLTs)
Timeframe: 21 days (single agent FAZ053) and 42 days (FAZ053+PDR001)
Dose interruptions and reductions
Timeframe: Up to approximately 41 months
Dose intensity
Timeframe: Up to approximately 41 months