Study of the Safety and Efficacy of MIW815 With PDR001 to Patients With Advanced/Metastatic Solid Tumours or Lymphomas

Titre officiel

A Phase I, Open Label, Multicentre Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoural Injection to Patients With Advanced/Metastatic Solid Tumours or Lymphomas

Sommaire:

Cette étude vise à caractériser l’innocuité, la tolérabilité, les paramètres pharmacocinétiques et pharmacodynamiques et l’activité antitumorale du MIW815 (ADU-S100) en association avec le PDR001.

Description de l'essai

Primary Outcome:

  • Incidence of dose limiting toxicities (DLTs)
Secondary Outcome:
  • AUC last
  • AUC tau
  • AUC inf
  • Cmax
  • Tmax
  • Cmin
  • Lambda_z
  • T1/2
  • CL/F
  • Vz/F
  • Best overall response (BOR)
  • Overall response rate (ORR)
  • Progression free survival (PFS)
  • Disease control rate (DCR)
  • Time to response (TTR)
  • Tumour infiltrating lymphocytes (TIL)
  • Cytokines
This is a Phase Ib, multi-centre, open-label study to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumour activity of MIW815(ADU-S100) in combination with the PD-1 checkpoint inhibitor PDR001. Two different schedules will be explored in two dose escalation groups in accessible cutaneous or subcutaneous lesions, as well as an optional dose confirmation group exploring intratumoural injection of viscerally located lesions. Group A will include patients with accessible solid tumours and lymphomas. This group will receive a fixed dose of PDR001 i.v. on day 1 of every 28 day cycle and intratumoural injections of MIW815 (ADU-S100) on days 1, 8 and 15 of every 28 day cycle. Group B will include patients with accessible solid tumours and lymphomas. This group will receive a fixed dose of PDR001 i.v. on day 1 of every cycle and an intratumoural injection of MIW815 (ADU-S100) on day 1 of every cycle. Once the dose and dose schedule has been confirmed, the dose expansion part of the study will open. The main purpose of the expansion part is to further assess the safety and tolerability, as well as preliminary anti-tumour activity, of the study treatment at the maximum tolerated dose and/or recommended dose for expansion. .

Voir cet essai sur ClinicalTrials.gov

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