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A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
Sponsor: Servier Bio-Innovation LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-08-31
Completion Date
2027-08
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
S095029
Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).
pembrolizumab 200 mg (KEYTRUDA ®)
Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W).
Locations (49)
Ocala Oncology Center Pl
Ocala, Florida, United States
Investigative Clinical Research of Indiana, Llc
Noblesville, Indiana, United States
MD Anderson Cancer Center
Houston, Texas, United States
The Queen Elizabeth Hospital
Woodville South, Australia
Ordensklinikum Linz
Linz, Upper Austria, Austria
Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)
Vienna, Vienna, Austria
Landeskrankenhaus (SALK)
Salzburg, Austria
UZ Leuven Campus Gasthuisberg
Leuven, Belgium
Chu de Liege
Liège, Belgium
Cepon - Centro de Pesquisas Oncologicas
Florianópolis, Brazil
Supera Oncologia
Santa Catarina, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, Brazil
Instituto Brasileiro de Controle Do Câncer
São Paulo, Brazil
Hospital Albert Einstein
São Paulo, Brazil
Mount Sinai Hospital
Toronto, Canada
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shandong Cancer Hospital Institute
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch
Hangzhou, Zhengjiang Province, China
Rigshospitalet
Copenhagen, Denmark
Odense Universitetshospital
Odense, Denmark
Institut Bergonié
Bordeaux, France
Centre Georges Francois Leclerc
Dijon, France
Chru Lille - Hopital Claude Huriez
Lille, France
Institut Curie
Saint-Cloud, France
Inst. de Cancer de L'ouest
Saint-Herblain, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France
Semmelweis Egyetem
Budapest, Hungary
Orszagos Onkologiai Intezet
Budapest, Hungary
Bugat Pal Hospital
Gyöngyös, Hungary
Bekes Megyei Kozponti Korhaz
Gyula, Hungary
A.O.U. Seconda Università Degli Studi Di Napoli
Campania, Italy
Fondazione IRCCS Istituto Nazionale dei Tumor
Milan, Italy
A.O.U. Pisana-Ospedale Santa Chiara
Pisa, Italy
Policlinico Universitario Agostino Gemelli
Rome, Italy
Policlinico G.B. Rossi A.O.U.I. Di Verona
Verona, Italy
Cancer Institute Hospital of Jfcr
Koto-Ku, Tokyo, Japan
National Cancer Center Hospital
Chou-ku, Japan
Osaka International Cancer Institute
Osaka, Japan
Pan American Center For Oncology Trials, Llc
Rio Piedras, Puerto Rico
University Hospital Vall D'Hebron Institute of Oncology (VHIO)
Barcelona, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Universitario de Valencia
Valencia, Spain
The Royal Marsden in Chelsea
London, United Kingdom
The Royal Marsden in Sutton
Sutton, Surrey, United Kingdom