TIG-006

• Research type

  Research Study

• Full title

  A Multicenter, Open-Label, Phase I/II Study of EOS884448 in combination with standard of care and/or investigational therapies in participants with advanced solid tumors

• IRAS ID

  1005193

• Contact name

  Servane Warot

• Contact email

  servane.warot@iteostherapeutics.com

• Sponsor organisation

  iTeos Belgium SA

• Eudract number

  2021-001329-29

• Clinicaltrials.gov Identifier

  NCT05060432

• Research summary

  This is a multicentre, open-label, phase I/II basket study, evaluating the safety and tolerability, recommended phase 2 dose (RP2D), pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A) combined with standard of care and/or with investigational therapies in participants with advanced solid tumours. EOS-448 will be combined with pembrolizumab, a marketed anti-PD-1 antibody in one treatment arm and a second treatment arm will evaluate EOS-448 combined with inupadenant (EOS-100850), an investigational adenosine A2A receptor antagonist under development by the Sponsor.
  The study will be conducted in multiple stage parts:
  Part 1 consisted of multiple parallel or sequential dose finding cohorts evaluating safety and tolerability as well as determining the recommended phase 2 dose (RP2D) of;
  o EOS-448 combined with pembrolizumab (Part 1A),
  o EOS-448 combined with inupadenant (Parts 1B and 1C),
  o EOS-448 combined with dostarlimab (Part 1D),
  o inupadenant HCl combined with dostarlimab (Part 1E),
  o EOS-448 combined with inupadenant HCl and dostarlimab (Part 1F) in participants with advanced solid tumors and,
  o EOS-448 combined with dostarlimab and standard of care chemotherapies in participants with 1L mNSCLC (Part 1G).
  Part 2 is the expansion part of the study. It will further explore the safety, tolerability, anti-tumour activity as well as pharmacokinetics and pharmacodynamics of;
  o EOS-448 combined with pembrolizumab in participants with PD-L1 positive first line (1L) mNSCLC (Part 2A and 2B)
  o EOS-448 combined with dostarlimab in participants with PD-L1 positive 1L mHNSCC (Part 2C and 2D)
  o EOS-448 combined with inupadenant HCl in participants with anti-PD-(L)1 resistant metastatic cutaneous melanoma (Part 2E),treated at the respective combinations RP2D.
  The study will be conducted at multiple centres in the UK with Professor Harrington at the Royal Marsden NHS Foundation Trust, serving as NCI.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  22/NE/0127

• Date of REC Opinion

  17 Oct 2022

• REC opinion

  Further Information Favourable Opinion