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New antibody combo takes on Hard-to-Treat stomach cancers

NCT ID NCT06116136

Disease control Sponsor: Servier Bio-Innovation LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new antibody drug, S095029, combined with the immunotherapy pembrolizumab in people with advanced stomach or gastro-esophageal junction cancer that has a specific genetic feature (MSI-H/dMMR). The trial aims to see if the combination is safe and can shrink tumors. About 48 participants will receive the drugs every three weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
S095029 (an antibody that blocks NKG2A) combined with pembrolizumab (an immunotherapy)
What this could lead to
If successful, this combination could offer a new treatment option for people with a specific type of advanced stomach or esophageal cancer that has not responded well to prior therapy.
What could go wrong
This is an early-phase trial with only 48 participants, so results may not apply broadly. The combination may cause side effects or fail to shrink tumors in many patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

48 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Msi-H/DMMR gastric cancer Msi-H/DMMR gastroesophageal-junction cancer

Contacts and locations

Locations

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

    Pisa, 56126, Italy

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

    Campania, 80131, Italy

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Bekes Megyei Kozponti Korhaz

    Gyula, 05700, Hungary

  • Bugat Pal Hospital

    Gyöngyös, 3200, Hungary

  • Cancer Institute Hospital of Jfcr

    Koto-Ku, Tokyo, 1358550, Japan

  • Centre Georges Francois Leclerc

    Dijon, 21079, France

  • Cepon - Centro de Pesquisas Oncologicas

    Florianópolis, 88034-000, Brazil

  • Chru Lille - Hopital Claude Huriez

    Lille, 59037, France

  • Chu de Liege

    Liège, 4000, Belgium

  • Fondazione IRCCS Istituto Nazionale dei Tumor

    Milan, 20133, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201321, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003, China

  • Hospital Albert Einstein

    São Paulo, 05652- 900, Brazil

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario de Valencia

    Valencia, 46010, Spain

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000, Brazil

  • Inst. de Cancer de L'ouest

    Saint-Herblain, 44805, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Curie

    Saint-Cloud, 92064, France

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

  • Instituto Brasileiro de Controle Do Câncer

    São Paulo, 04014-002, Brazil

  • Investigative Clinical Research of Indiana, Llc

    Noblesville, Indiana, 46062, United States

  • Landeskrankenhaus (SALK)

    Salzburg, 5020, Austria

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042, China

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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

    Vienna, State of Vienna, 01090, Austria

  • Mount Sinai Hospital

    Toronto, M5G 1X5, Canada

  • National Cancer Center Hospital

    Chou-ku, 104-0045, Japan

  • Ocala Oncology Center Pl

    Ocala, Florida, 34474, United States

  • Odense Universitetshospital

    Odense, 5000, Denmark

  • Ordensklinikum Linz

    Linz, Upper Austria, 04010, Austria

  • Orszagos Onkologiai Intezet

    Budapest, 01122, Hungary

  • Osaka International Cancer Institute

    Osaka, 5418567, Japan

  • Pan American Center For Oncology Trials, Llc

    Rio Piedras, 00935, Puerto Rico

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

    Verona, 37134, Italy

  • Policlinico Universitario Agostino Gemelli

    Rome, 00168, Italy

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Semmelweis Egyetem

    Budapest, 01083, Hungary

  • Shandong Cancer Hospital Institute

    Jinan, Shandong, 250117, China

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

    Hangzhou, Zhengjiang Province, 310000, China

  • Supera Oncologia

    Santa Catarina, 89812-211, Brazil

  • The Queen Elizabeth Hospital

    Woodville South, 5011, Australia

  • The Royal Marsden in Chelsea

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden in Sutton

    Sutton, Surrey, SM2 5PT, United Kingdom

  • UZ Leuven Campus Gasthuisberg

    Leuven, 3000, Belgium

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

    Barcelona, 08035, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.