A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.

Last updated: April 2, 2026
Sponsor: Servier Bio-Innovation LLC
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Stomach Cancer

Digestive System Neoplasms

Gastric Cancer

Treatment

pembrolizumab 200 mg (KEYTRUDA ®)

S095029

Pembrolizumab 200 mg

Clinical Study ID

NCT06116136
CL1-95029-002
Keynote E70
2023-507995-33
MK-3475-E70
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a confirmed diagnosis of locally advanced and unresectable or metastaticgastric or gastro-esophageal junction adenocarcinoma

  • Participants' tumor must have an MSI-H/dMMR status according to institutionalguidelines and/or according to the College of American Pathologists, determined atany time prior to enrolment.

Exclusion

Exclusion Criteria:

  • Has received more than one previous line of treatment in the locally advanced andunresectable or metastatic setting.

  • Has received prior therapy with any checkpoint inhibitor (anti-PD-1, anti-programmedcell death ligand 1 (PDL1), anti-CTLA4).

  • Participants who have received prior systemic anti-cancer therapy includinginvestigational agents within 4 weeks (shorter interval, at least 5 half-lives, forkinase 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 participantswho have not recovered from the side effects of the surgery.

Study Design

Total Participants: 48
Treatment Group(s): 3
Primary Treatment: pembrolizumab 200 mg (KEYTRUDA ®)
Phase: 1/2
Study Start date:
August 31, 2024
Estimated Completion Date:
August 31, 2027

Study Description

This Phase 1b/2 study will be conducted in two parts; a safety lead-in part (Phase 1b) to identify the RP2D of S095029 in combination with pembrolizumab and an expansion part (Phase 2) to evaluate anti-tumor activity and safety in participants with locally advanced unresectable or metastatic MSI-H/dMMR gastric /GEJ adenocarcinomas.

Connect with a study center

  • The Queen Elisabeth Hospital

    Woodville South, South Australia 5011
    Australia

    Active - Recruiting

  • The Queen Elizabeth Hospital

    Woodville South, 5011
    Australia

    Site Not Available

  • The Queen Elizabeth Hospital

    Woodville South 9973101, 5011
    Australia

    Site Not Available

  • Ordensklinikum Linz

    Linz, Upper Austria 04010
    Austria

    Site Not Available

  • Ordensklinikum Linz

    Linz 2772400, Upper Austria 2769848 04010
    Austria

    Site Not Available

  • Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)

    Vienna, Vienna 01090
    Austria

    Site Not Available

  • Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)

    Wien, Vienna 01090
    Austria

    Site Not Available

  • Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)

    Vienna 2761369, Vienna 2761367 01090
    Austria

    Site Not Available

  • Landeskrankenhaus (SALK)

    Salzburg, 5020
    Austria

    Site Not Available

  • Landeskrankenhaus (SALK)

    Salzburg 2766824, 5020
    Austria

    Site Not Available

  • UZ Leuven Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven Campus Gasthuisberg

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Chu de Liege

    Liège, 4000
    Belgium

    Site Not Available

  • Chu de Liege

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • Cepon - Centro de Pesquisas Oncologicas

    Florianópolis, 88034-000
    Brazil

    Site Not Available

  • Cepon - Centro de Pesquisas Oncologicas

    Florianópolis 3463237, 88034-000
    Brazil

    Site Not Available

  • Supera Oncologia

    Santa Catarina, 89812-211
    Brazil

    Site Not Available

  • Supera Oncologia

    Santa Catarina 3389702, 89812-211
    Brazil

    Site Not Available

  • Hospital Albert Einstein

    Sao Paulo, 05652- 900
    Brazil

    Active - Recruiting

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    Sao Paulo, 01246-000
    Brazil

    Active - Recruiting

  • Instituto Brasileiro de Controle Do Câncer

    Sao Paulo, 04014-002
    Brazil

    Site Not Available

  • Hospital Albert Einstein

    São Paulo, 05652- 900
    Brazil

    Site Not Available

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • Instituto Brasileiro de Controle Do Câncer

    São Paulo, 04014-002
    Brazil

    Site Not Available

  • Hospital Albert Einstein

    São Paulo 3448439, 05652- 900
    Brazil

    Site Not Available

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo 3448439, 01246-000
    Brazil

    Site Not Available

  • Instituto Brasileiro de Controle Do Câncer

    São Paulo 3448439, 04014-002
    Brazil

    Site Not Available

  • Mount Sinai Hospital

    Toronto, M5G 1X5
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto 6167865, M5G 1X5
    Canada

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality 100142
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100142
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin 2037013, Heilongjiang 2036965 150081
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450003
    China

    Site Not Available

  • Liaoning Cancer Hospital

    Shenyang, Liaoning 110042
    China

    Site Not Available

  • Liaoning Cancer Hospital

    Shenyang 2034937, Liaoning 2036115 110042
    China

    Site Not Available

  • Shandong Cancer Hospital Institute

    Jinan, Shandong 250117
    China

    Site Not Available

  • Shandong Cancer Hospital Institute

    Jinan 1805753, Shandong 1796328 250117
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality 201321
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236, Shanghai Municipality 1796231 201321
    China

    Site Not Available

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch

    Hangzhou, Zhengjiang Province 310000
    China

    Site Not Available

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch

    Hangzhou 1808926, Zhengjiang Province 310000
    China

    Site Not Available

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen 2618425, 2100
    Denmark

    Site Not Available

  • Odense Universitetshospital

    Odense, 5000
    Denmark

    Site Not Available

  • Odense Universitetshospital

    Odense 2615876, 5000
    Denmark

    Site Not Available

  • Institut Bergonié

    Bordeaux, 33076
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux 3031582, 33076
    France

    Site Not Available

  • Centre Georges Francois Leclerc

    Dijon, 21079
    France

    Site Not Available

  • Centre Georges Francois Leclerc

    Dijon 3021372, 21079
    France

    Site Not Available

  • Chru Lille - Hopital Claude Huriez

    Lille, 59037
    France

    Site Not Available

  • Chru Lille - Hopital Claude Huriez

    Lille 2998324, 59037
    France

    Site Not Available

  • Inst. de Cancer de L'ouest

    Saint Herblain, 44805
    France

    Site Not Available

  • Institut Curie

    Saint-Cloud, 92064
    France

    Site Not Available

  • Institut Curie

    Saint-Cloud 2981041, 92064
    France

    Site Not Available

  • Inst. de Cancer de L'ouest

    Saint-Herblain, 44805
    France

    Site Not Available

  • Inst. de Cancer de L'ouest

    Saint-Herblain 2979590, 44805
    France

    Site Not Available

  • Institut de Cancerologie de Lorraine

    Vandoeuvre-les-Nancy Cedex, 54519
    France

    Site Not Available

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519
    France

    Site Not Available

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy 2970797, 54519
    France

    Site Not Available

  • Orszagos Onkologiai Intezet

    Budapest, 01122
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 01083
    Hungary

    Site Not Available

  • Orszagos Onkologiai Intezet

    Budapest 3054643, 01122
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest 3054643, 01083
    Hungary

    Site Not Available

  • Bekes Megyei Kozponti Korhaz

    Gyula, 05700
    Hungary

    Site Not Available

  • Bekes Megyei Kozponti Korhaz

    Gyula 720334, 05700
    Hungary

    Site Not Available

  • Bugat Pal Hospital

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • Bugat Pal Hospital

    Gyöngyös 3052040, 3200
    Hungary

    Site Not Available

  • A.O.U. Seconda Università Degli Studi Di Napoli

    Campania, 80131
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumor

    Milan, 20133
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumor

    Milan 3173435, 20133
    Italy

    Site Not Available

  • A.O.U. Pisana-Ospedale Santa Chiara

    Pisa, 56126
    Italy

    Site Not Available

  • A.O.U. Pisana-Ospedale Santa Chiara

    Pisa 3170647, 56126
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Rome, 00168
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Rome 3169070, 00168
    Italy

    Site Not Available

  • Policlinico G.B. Rossi A.O.U.I. Di Verona

    Verona, 37134
    Italy

    Site Not Available

  • Policlinico G.B. Rossi A.O.U.I. Di Verona

    Verona 3164527, 37134
    Italy

    Site Not Available

  • Cancer Institute Hospital of Jfcr

    Koto-Ku, Tokyo 1358550
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chou-ku, 104-0045
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Osaka, 5418567
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Osaka 1853909, 5418567
    Japan

    Site Not Available

  • Pan American Center For Oncology Trials, Llc

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Pan American Center For Oncology Trials, Llc

    Rio Piedras 4829037, 00935
    Puerto Rico

    Site Not Available

  • University Hospital Val De Hebron Institute of Oncology (VHIO)

    Barcelona, 8035
    Spain

    Active - Recruiting

  • University Hospital Vall D'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035
    Spain

    Site Not Available

  • University Hospital Vall D'Hebron Institute of Oncology (VHIO)

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Gregorio Marañón

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander 3109718, 39008
    Spain

    Site Not Available

  • Hospital Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitario de Valencia

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Belfast City Hospital - Northern Ireland Cancer Centre

    Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • The Royal Marsden in Chelsea

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • The Royal Marsden in Chelsea

    London 2643743, SW3 6JJ
    United Kingdom

    Site Not Available

  • The Royal Marsden in Sutton

    Sutton, Surrey, SM2 5PT
    United Kingdom

    Site Not Available

  • The Royal Marsden in Sutton

    Sutton, Surrey 2636503, SM2 5PT
    United Kingdom

    Site Not Available

  • Ocala Oncology Center Pl

    Ocala, Florida 34474
    United States

    Site Not Available

  • Ocala Oncology Center Pl

    Ocala 4166673, Florida 4155751 34474
    United States

    Site Not Available

  • Investigative Clinical Research of Indiana, Llc

    Noblesville, Indiana 46062
    United States

    Site Not Available

  • Investigative Clinical Research of Indiana, Llc

    Noblesville 4924198, Indiana 4921868 46062
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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