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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
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

Full criteria on ClinicalTrials.gov

Sites (43)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ordensklinikum Linz GmbH
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LinzAustriaCompleted
SCRI CCCIT Ges.m.b.H.
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SalzburgAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
The Queen Elizabeth Hospital
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Woodville SouthAustraliaUnknown status
UZ Leuven
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LeuvenBelgiumActive, not recruiting
CEPON - Centro de Pesquisas Oncologicas
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FlorianópolisBrazilUnknown status
Supera Oncologia
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Santa CatarinaBrazilUnknown status
Hospital Albert Einstein
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São PauloBrazilUnknown status
Instituto Brasileiro de Controle Do Câncer
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São PauloBrazilUnknown status
Icesp - Instituto Do Câncer Do Estado de São Paulo
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São PauloBrazilUnknown status
Mount Sinai Hospital
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TorontoCanadaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Shandong Cancer Hospital & institute
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JinanChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Liaoning Cancer Hospital
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ShenyangChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Institut Bergonie
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BordeauxFranceActive, not recruiting
Centr Georges Francois Leclerc
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DijonFranceActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Institut De Cancerologie De L Ouest
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St HerblainFranceActive, not recruiting
The Royal Marsden in Chelsea
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LondonUnited KingdomUnknown status
The Royal Marsden in Sutton
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Sutton, SurreyUnited KingdomUnknown status
Semmelweis Egyetem
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BudapestHungaryCompleted
Orszagos Onkologiai Intezet
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Budapest XIIHungaryCompleted
Clinexpert Kft.
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GyongyosHungaryCompleted
Bekes Varmegyei Koezponti Korhaz
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GyulaHungaryCompleted
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyActive, not recruiting
National Cancer Center Hospital
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Chou-kuJapanUnknown status
Cancer Institute Hospital of JFCR
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Koto-KuJapanUnknown status
Osaka International Cancer Institute
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OsakaJapanUnknown status
Pan American Center for Oncology Trials LLC
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Rio PiedrasPuerto RicoUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Investigative Clinical Research of Indiana, LLC
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NoblesvilleUnited StatesUnknown status
Ocala Oncology Center PL
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OcalaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.