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
4 other identifiers
interventional
48
14 countries
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2024
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedStudy Start
First participant enrolled
August 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
March 16, 2026
March 1, 2026
1.9 years
September 28, 2023
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Dose-Limiting Toxicities (DLTs)
Phase 1b and Phase 2
At the end of Cycle 1 (each cycle is 21 days)
Total Number of Adverse Events (AEs)
Phase 1b and Phase 2
From screening to 90 days after the last dose
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
Phase 1b and Phase 2
From screening to 90 days after the last dose
Adverse Events (AEs) Leading to Dose Discontinuation
Phase 1b and Phase 2
From screening to 90 days after the last dose
Objective Response Rate (ORR)
Phase 2 ONLY. The Proportion of participants who achieve complete response (CR) or partial response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Approximately 2 years
Secondary Outcomes (7)
Duration of Response (DoR)
Approximately 2 years
Progression-Free Survival (PFS)
Approximately 2 years
Disease Control Rate (DCR)
Approximately 2 years
Overall Survival (OS)
Approximately 2 years
Trough Concentrations of S095029 (Ctrough)
From first dose to 30 days after the last dose
- +2 more secondary outcomes
Study Arms (1)
S095029 and pembrolizumab
EXPERIMENTALParticipants 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.
Interventions
Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).
Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Servier Bio-Innovation LLClead
- Merck Sharp & Dohme LLCcollaborator
- Institut de Recherches Internationales Serviercollaborator
Study Sites (49)
Ocala Oncology Center Pl
Ocala, Florida, 34474, United States
Investigative Clinical Research of Indiana, Llc
Noblesville, Indiana, 46062, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
The Queen Elizabeth Hospital
Woodville South, 5011, Australia
Ordensklinikum Linz
Linz, Upper Austria, 04010, Austria
Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)
Vienna, Vienna, 01090, Austria
Landeskrankenhaus (SALK)
Salzburg, 5020, Austria
UZ Leuven Campus Gasthuisberg
Leuven, 3000, Belgium
Chu de Liege
Liège, 4000, Belgium
Cepon - Centro de Pesquisas Oncologicas
Florianópolis, 88034-000, Brazil
Supera Oncologia
Santa Catarina, 89812-211, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000, Brazil
Instituto Brasileiro de Controle Do Câncer
São Paulo, 04014-002, Brazil
Hospital Albert Einstein
São Paulo, 05652- 900, Brazil
Mount Sinai Hospital
Toronto, M5G 1X5, Canada
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
Shandong Cancer Hospital Institute
Jinan, Shandong, 250117, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch
Hangzhou, Zhengjiang Province, 310000, China
Rigshospitalet
Copenhagen, 2100, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Institut Bergonié
Bordeaux, 33076, France
Centre Georges Francois Leclerc
Dijon, 21079, France
Chru Lille - Hopital Claude Huriez
Lille, 59037, France
Institut Curie
Saint-Cloud, 92064, France
Inst. de Cancer de L'ouest
Saint-Herblain, 44805, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Semmelweis Egyetem
Budapest, 01083, Hungary
Orszagos Onkologiai Intezet
Budapest, 01122, Hungary
Bugat Pal Hospital
Gyöngyös, 3200, Hungary
Bekes Megyei Kozponti Korhaz
Gyula, 05700, Hungary
A.O.U. Seconda Università Degli Studi Di Napoli
Campania, 80131, Italy
Fondazione IRCCS Istituto Nazionale dei Tumor
Milan, 20133, Italy
A.O.U. Pisana-Ospedale Santa Chiara
Pisa, 56126, Italy
Policlinico Universitario Agostino Gemelli
Rome, 00168, Italy
Policlinico G.B. Rossi A.O.U.I. Di Verona
Verona, 37134, Italy
Cancer Institute Hospital of Jfcr
Koto-Ku, Tokyo, 1358550, Japan
National Cancer Center Hospital
Chou-ku, 104-0045, Japan
Osaka International Cancer Institute
Osaka, 5418567, Japan
Pan American Center For Oncology Trials, Llc
Rio Piedras, 00935, Puerto Rico
University Hospital Vall D'Hebron Institute of Oncology (VHIO)
Barcelona, 08035, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario de Valencia
Valencia, 46010, Spain
The Royal Marsden in Chelsea
London, SW3 6JJ, United Kingdom
The Royal Marsden in Sutton
Sutton, Surrey, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2023
First Posted
November 3, 2023
Study Start
August 31, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorization in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.