MSI-H/dMMR Gastroesophageal-junction CancerPhase 1/2NCT06116136
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
A Phase 1/2 study testing S095029 and pembrolizumab 200 mg (KEYTRUDA ®) in people with MSI-H/dMMR Gastroesophageal-junction Cancer and MSI-H/dMMR Gastric Cancer, run by Servier Bio-Innovation LLC at 49 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MSI-H/dMMR Gastroesophageal-junction Cancer, MSI-H/dMMR Gastric Cancer
- What is being tested?
- S095029 and pembrolizumab 200 mg (KEYTRUDA ®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 49 sitesin 15 countries
- Study dates
- 31 Aug 2024to Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
49 sites in 15 countries.
49 sites in 15 countries
China7 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch
Hangzhou, Zhengjiang Province, 310000
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Shandong Cancer Hospital Institute
Jinan, Shandong, 250117
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Henan Cancer Hospital
Zhengzhou, Henan, 450003
France6 sites
Institut Bergonié
Bordeaux, 33076
Centre Georges Francois Leclerc
Dijon, 21079
Chru Lille - Hopital Claude Huriez
Lille, 59037
Institut Curie
Saint-Cloud, 92064
Inst. de Cancer de L'ouest
Saint-Herblain, 44805
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Brazil5 sites
Cepon - Centro de Pesquisas Oncologicas
Florianópolis, 88034-000
Supera Oncologia
Santa Catarina, 89812-211
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
Instituto Brasileiro de Controle Do Câncer
São Paulo, 04014-002
Hospital Albert Einstein
São Paulo, 05652- 900
Italy5 sites
A.O.U. Seconda Università Degli Studi Di Napoli
Campania, 80131
Fondazione IRCCS Istituto Nazionale dei Tumor
Milan, 20133
A.O.U. Pisana-Ospedale Santa Chiara
Pisa, 56126
Policlinico Universitario Agostino Gemelli
Rome, 00168
Policlinico G.B. Rossi A.O.U.I. Di Verona
Verona, 37134
Hungary4 sites
Semmelweis Egyetem
Budapest, 01083
Orszagos Onkologiai Intezet
Budapest, 01122
Bugat Pal Hospital
Gyöngyös, 3200
Bekes Megyei Kozponti Korhaz
Gyula, 05700
Spain4 sites
University Hospital Vall D'Hebron Institute of Oncology (VHIO)
Barcelona, 08035
Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Universitario de Valencia
Valencia, 46010
United States3 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Investigative Clinical Research of Indiana, Llc
Noblesville, Indiana, 46062
Ocala Oncology Center Pl
Ocala, Florida, 34474
Austria3 sites
Ordensklinikum Linz
Linz, Upper Austria, 04010
Landeskrankenhaus (SALK)
Salzburg, 5020
Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)
Vienna, State of Vienna, 01090
Japan3 sites
National Cancer Center Hospital
Chou-ku, 104-0045
Cancer Institute Hospital of Jfcr
Koto-Ku, Tokyo, 1358550
Osaka International Cancer Institute
Osaka, 5418567
Belgium2 sites
UZ Leuven Campus Gasthuisberg
Leuven, 3000
Chu de Liege
Liège, 4000
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Odense Universitetshospital
Odense, 5000
United Kingdom2 sites
The Royal Marsden in Chelsea
London, SW3 6JJ
The Royal Marsden in Sutton
Sutton, Surrey, SM2 5PT
Puerto Rico1 site
Pan American Center For Oncology Trials, Llc
Rio Piedras, 00935
About this study
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
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.
Read the detailed 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.
- Being tested
- S095029, pembrolizumab 200 mg (KEYTRUDA ®)
- Keywords
- Anti-NKG2A, S095029, pembrolizumab, MSI-H/dMMR, Gastric cancer, Gastroesophageal-junction cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S095029Drug
Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).
pembrolizumab 200 mg (KEYTRUDA ®)Drug
Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| S095029 and pembrolizumab | Experimental | 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. Receives: Drug: S095029; Drug: pembrolizumab 200 mg (KEYTRUDA ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dose-Limiting Toxicities (DLTs)
Phase 1b and Phase 2
Measured: At the end of Cycle 1 (each cycle is 21 days)
Total Number of Adverse Events (AEs)
Phase 1b and Phase 2
Measured: From screening to 90 days after the last dose
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
Phase 1b and Phase 2
Measured: From screening to 90 days after the last dose
Adverse Events (AEs) Leading to Dose Discontinuation
Phase 1b and Phase 2
Measured: 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.
Measured: Approximately 2 years
Secondary outcomes (7)
Duration of Response (DoR)
Phase 1b and Phase 2. The time from the first documentation of complete response (CR) or partial response (PR) until the documented progressive disease (PD) or death, as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST).
Measured: Approximately 2 years
Progression-Free Survival (PFS)
Phase 1b and Phase 2. The time from the first dose of S095029 to first documented PD or death due to any cause, whichever occurs first, as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST).
Measured: Approximately 2 years
Disease Control Rate (DCR)
Phase 1b and Phase 2. The proportion of participants who achieved stable disease (SD), PR, or CR (based on participant's best response), as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST).
Measured: Approximately 2 years
Overall Survival (OS)
Phase 1b and Phase 2. The time from first S095029 dose to death due to any cause.
Measured: Approximately 2 years
Trough Concentrations of S095029 (Ctrough)
Phase 1b and Phase 2.
Measured: From first dose to 30 days after the last dose
Concentration of potential antibodies directed against S095029
Phase 1b and Phase 2.
Measured: From screening to 30 days after the last dose, or end of study if clinically indicated
Objective Response Rate (ORR)
Phase 1b ONLY. The Proportion of participants who achieve complete response (CR) or partial response (PR), as per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start31 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSI-H/dMMR Gastroesophageal-junction CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Bio-Innovation LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC, Institut de Recherches Internationales Servier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116136
- Sponsor's protocol ID
- CL1-95029-002
- Other IDs
- Keynote E70, 2023-507995-33, MK-3475-E70, 2023
- Status last verified
- Apr 2026
- First submitted
- 28 Sep 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06116136
- Acronym / sponsor ID
- CL1-95029-002
- Keywords
- Anti-NKG2A, S095029, pembrolizumab, MSI-H/dMMR, Gastric cancer, Gastroesophageal-junction cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Servier Bio-Innovation LLCIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC, Institut de Recherches Internationales Servier
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S095029 and pembrolizumab | Experimental | Drug: S095029, Drug: pembrolizumab 200 mg (KEYTRUDA ®)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S095029Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W). | Drug | S095029 and pembrolizumab |
| pembrolizumab 200 mg (KEYTRUDA ®)Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W). | Drug | S095029 and pembrolizumab |
Primary outcome
Number of Dose-Limiting Toxicities (DLTs)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1b and Phase 2
Total Number of Adverse Events (AEs)
Time frame: From screening to 90 days after the last dose
Phase 1b and Phase 2
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
Time frame: From screening to 90 days after the last dose
Phase 1b and Phase 2
Adverse Events (AEs) Leading to Dose Discontinuation
Time frame: From screening to 90 days after the last dose
Phase 1b and Phase 2
Objective Response Rate (ORR)
Time frame: Approximately 2 years
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.
7 secondary outcomes
Duration of Response (DoR)
Time frame: Approximately 2 years
Progression-Free Survival (PFS)
Time frame: Approximately 2 years
Disease Control Rate (DCR)
Time frame: Approximately 2 years
Overall Survival (OS)
Time frame: Approximately 2 years
Trough Concentrations of S095029 (Ctrough)
Time frame: From first dose to 30 days after the last dose
Concentration of potential antibodies directed against S095029
Time frame: From screening to 30 days after the last dose, or end of study if clinically indicated
Objective Response Rate (ORR)
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S095029 and pembrolizumab 200 mg (KEYTRUDA ®) in people with MSI-H/dMMR Gastroesophageal-junction Cancer and MSI-H/dMMR Gastric Cancer, run by Servier Bio-Innovation LLC at 49 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in China, France, Brazil, Italy, Hungary and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Dose-Limiting Toxicities (DLTs) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.