Active Cancer NIHR-supported project Digestion, Kidneys & Other Organs

Open-label, non-randomized, Phase 1b/2 trial investigating the safety, tolerability, and antitumor activity of S095029 (anti-NKG2A antibody) as a part of combination therapy in participants with locally advanced and unresectable or metastatic MSI-H/dMMR gastroesophageal junction/gastric cancer

In plain English

AI plain-English summary

A new drug combination is being tested in people with advanced stomach cancer that has spread to other parts of the body. This matters because gastric and gastroesophageal junction cancers that are mismatch repair deficient (MSI-H/dMMR) often do not respond well to standard treatments, and new options are urgently needed. The study combines S095029, an experimental antibody that blocks a natural brake on immune cells called NKG2A, with pembrolizumab, an existing immunotherapy that releases a different immune checkpoint. The idea is that blocking two separate immune-suppressing pathways at once might shrink tumours that resist single-agent immunotherapy. If the combination proves safe and active, it could offer a new treatment pathway for patients with this specific genetic subtype of stomach cancer, who currently have limited choices. The research is a clinical trial, not fundamental science—it directly tests a potential therapy in people. Success would mean a new drug regimen entering later-stage trials, potentially changing clinical practice for a hard-to-treat cancer population.

View original technical description
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).

Researchers

Naureen Starling (Principal Investigator)

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Original classification

Immunotherapeutics

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