NCT06116136Active, not recruitingPhase 1/2
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
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 Gastro-esophageal Junction /Gastric Cancer
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
This study will investigate the safety, tolerability, and antitumor activity of S095029 (anti-NKG2A antibody) in combination with pembrolizumab in in microsatellite instability-high/Defective mismatch repair (MSI-H/dMMR) locally advanced unresectable or metastatic gastric /GEJ adenocarcinomas.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 28 Sept 2023
- Start date
- 31 Aug 2024
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Servier Bio-Innovation LLC
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06116136
- EU CT number
- 2023-507995-33-00
- EudraCT number
- 2023-507995-33
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 48
- From 31 Aug 2024 to the primary completion date, 31 Aug 2027
- 43 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received more than one previous line of treatment in the locally advanced and unresectable or metastatic setting.
- Has received prior therapy with any checkpoint inhibitor (anti-PD-1, anti-programmed cell death ligand 1 (PDL1), anti-CTLA4).
- Participants who have received prior systemic anti-cancer therapy including investigational agents within 4 weeks (shorter interval, at least 5 half-lives, for kinase inhibitors or other short half-life drugs) prior to first study treatment.
- Prior radiotherapy if completed less than 2 weeks before first study treatment
- Major surgery less than 4 weeks prior to the first study treatment or participants who have not recovered from the side effects of the surgery.
Who the study is looking for
- Have a confirmed diagnosis of locally advanced and unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
- Participants' tumor must have an MSI-H/dMMR status according to institutional guidelines and/or according to the College of American Pathologists, determined at any time prior to enrolment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (43)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Completed |
| SCRI CCCIT Ges.m.b.H. Coordinator of this site? Confirm its status | Salzburg | Austria | Completed |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville South | Australia | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| CEPON - Centro de Pesquisas Oncologicas Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| Supera Oncologia Coordinator of this site? Confirm its status | Santa Catarina | Brazil | Unknown status |
| Hospital Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto Brasileiro de Controle Do Câncer Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Icesp - Instituto Do Câncer Do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Shandong Cancer Hospital & institute Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | St Herblain | France | Active, not recruiting |
| The Royal Marsden in Chelsea Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Royal Marsden in Sutton Coordinator of this site? Confirm its status | Sutton, Surrey | United Kingdom | Unknown status |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Gyongyos | Hungary | Completed |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Completed |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Active, not recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chou-ku | Japan | Unknown status |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Koto-Ku | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Pan American Center for Oncology Trials LLC Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Investigative Clinical Research of Indiana, LLC Coordinator of this site? Confirm its status | Noblesville | United States | Unknown status |
| Ocala Oncology Center PL Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.