Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

Official Title

A Phase I/II, Open Label, Multicentre Study of the Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 Administered to Patients With Advanced Malignancies

Summary:

This study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumour activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumours. The study consists of a dose escalation phase (I) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion phase (II) which will characterize treatment of LAG525 as a single agent and in combination with PDR001 at the MTD or RP2D.

Trial Description

Primary Outcome:

  • Phase I part: Incidence of dose limiting toxicities (DLTs)
  • Phase II part: Overall response Rate per RECIST V1.1
Secondary Outcome:
  • AUC
  • Presence and/ or concentration of anti-LAG525 and anti-PDR001 antibodies
  • Correlation of PD-L1, Lymphocyte activation gene-3 LAG-3 expression
  • Overall response Rate (ORR)
  • Expression of IFN-γ immune-related genes by mRNA profiling
  • Safety incidence of Adverse Events (AEs
  • Tolerability measured by dose interruptions
  • Progression free survival (PFS)
  • Duration of response (DOR)
  • Disease control rate (DCR)
  • Safety measuresd by incidence of Serious Adverse Events (SAEs)
  • Cmax
  • Tmax
  • half-life
  • Tolerability measured by dose reductions

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