CL1-95029-002

• Research type

  Research Study

• Full title

  Open-label, non-randomized, Phase 1b/2 trial investigating the safety, tolerability, and antitumor activity of S095029 (antiNKG2A antibody) as a part of combination therapy in participants with locally advanced and unresectable or metastatic MSIH/dMMR gastroesophageal junction/gastric cancer

• IRAS ID

  1009260

• Contact name

  Sue Russell

• Contact email

  sue.russell@servier.com

• Sponsor organisation

  Institut de Recherches Internationales Servier (I.R.I.S.)

• Clinicaltrials.gov Identifier

  NCT06116136

• Research summary

  The purpose of this study is to evaluate the safety and activity of a new combination treatment regimen (S095029 and pembrolizumab) in people with gastric / gastroesophageal junction cancer that may have spread to other parts of the body (metastatic).
  This study has two main parts:
  • Phase 1b: mainly to study the safety of the combination of S095029 with pembrolizumab. At least 10 participants will be treated in this part of the study.
  • Phase 2: mainly to study the efficacy and safety of S095029 with pembrolizumab. Up to 32 participants will be treated in this part of the study.
  S095029 is an investigational drug developed by the Institut de Recherches Internationales Servier (I.R.I.S.). Pembrolizumab is a marketed immunotherapy treatment used to treat some solid tumours. S095029 and pembrolizumab will be administered via intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 (D1) of each 21-day cycle. The duration of treatment will not exceed 35 cycles (approximately 2 years).

• REC name

  London - South East Research Ethics Committee

• REC reference

  24/LO/0466

• Date of REC Opinion

  9 Jul 2024

• REC opinion

  Further Information Favourable Opinion