A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
NCT ID: NCT06116136
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2024-08-31
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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S095029 and pembrolizumab
Participants diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJ), not previously treated with checkpoint inhibitors (CPIs) may first be enrolled into a Phase 1b safety lead-in part which will be used to identify the recommended Phase 2 dose (RP2D) of S095029 in combination with pembrolizumab. During the Phase 2 part, participants will receive the recommended Phase 2 dose (RP2D) of S095029, along with pembrolizumab.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Institut de Recherches Internationales Servier
OTHER
Servier Bio-Innovation LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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Keynote E70
Identifier Type: OTHER
Identifier Source: secondary_id
2023-507995-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MK-3475-E70
Identifier Type: OTHER
Identifier Source: secondary_id
CL1-95029-002
Identifier Type: -
Identifier Source: org_study_id
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