A phase 1 study of GWN323 in combination with PDR001

• Research type

  Research Study

• Full title

  A Phase I/Ib open-label, multi-centre, dose escalation study of GWN323 (anti-GITR) as a single agent and in combination with PDR001 (anti-PD-1) in patients with advanced solid tumours and lymphomas

• IRAS ID

  201239

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2015-004206-42

• Duration of Study in the UK

  2 years, 6 months, 24 days

• Research summary

  This study is a First in Human, open-label, phase I/Ib, multi-centre study with a dose escalation part of GWN323 administered as a single agent or in combination with PDR001, followed by a dose expansion part. The dose escalation of GWN323 and PDR001 may commence after at least two dose levels of GWN323 as a single agent have been evaluated. Once the recommended doses for expansion (RDEs) of GWN323 as single agent or in combination with PDR001 are declared, respective dose expansion parts will commence.The dose escalation parts of the study (Arm A and Arm B) will be conducted in adults with relapsed or refractory solid tumours or lymphomas following standard of care treatment.
  The dose expansion part of the study will be conducted in patients with advanced/metastatic solid tumours in Non Small Cell Lung Cancer, Head & Neck Cancer and patients whose tumour has High FoxP3 expression
  The purpose of this study of GWN323 is to characterise the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti tumour activity of GWN323 administered i.v. as a single agent or in combination with PDR001 in adult patients with advanced solid tumours and lymphomas.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  16/NW/0408

• Date of REC Opinion

  27 Jul 2016

• REC opinion

  Further Information Favourable Opinion