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

Official Title

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

Summary:

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 regulatory T-cells. 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.

Trial Description

Primary Outcome:

  • Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
Secondary Outcome:
  • Serum concentration-time profiles of FAZ053 as single agent and FAZ053 in combination with PDR001.
  • Presence of anti-FAZ053 and anti-PDR001.
  • Concentration of anti-FAZ053 and anti-PDR001.
  • Receptor Occupancy (RO) profiles when FAZ053 is given as single agent and for FAZ053 in combination with PDR001.
  • Total soluble/shed PD-L1 concentration-time profiles when FAZ053 is given as single agent and for FAZ053 in combination with PDR001.
  • Histopathology of tumour infiltrating lymphocytes (TILs) by hematoxylin.
  • Histopathology of tumour infiltrating lymphocytes (TILs) by eosin (H&E) stain.
  • Overall response rate (ORR) per RECIST v1.1
  • Best overall response per RECIST v1.1
  • Disease control rate per RECIST 1.1
  • Progression free survival (PFS) per RECIST 1.1
  • Duration of response per RECIST 1.1
  • Overall response rate (ORR) per immune related Response Criteria (irRC).
  • Progression free survival (PFS) per immune related Response Criteria (irRC).
  • Characterization of Tumour Infiltrating Lymphocytes (TILs) by Immunohistochemistry (IHC)
  • Characterization of myeloid cell infiltrate by IHC (CD8,FoxP3, CD163,CD68).
  • Area under the curve (AUC) for FAZ053 as single agent and FAZ053 in combination with PDR001.
  • Cmax for FAZ053 as single agent and FAZ053 in combination with PDR001.
  • Tmax for FAZ053 as single agent and FAZ053 in combination with PDR001.
  • Half-life for FAZ053 as single agent and FAZ053 in combination with PDR001.
  • Clast for FAZ053 as single agent and FAZ053 in combination with PDR001.
  • Tlast for FAZ053 as single agent and FAZ053 in combination with PDR001.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society