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) are aggressive and often stop responding to existing immunotherapies. The experimental drug S095029 blocks a protein called NKG2A on immune cells, which may help the immune system recognise and attack tumours more effectively when combined with the existing immunotherapy pembrolizumab. Current treatment options for these patients are limited, and new combinations are urgently needed. If the combination proves safe and active, it could offer a new treatment pathway for people with these hard-to-treat cancers. The study is a small early-phase trial designed to establish whether the regimen is worth testing in larger studies. It does not aim to change clinical practice immediately, but to generate the safety and efficacy data needed to justify further investigation. The researchers are not claiming a breakthrough—they are systematically checking whether this particular two-drug combination works better than either drug alone in a patient group with few remaining options.

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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