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Evaluating S095029 with pembrolizumab for advanced 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

Phase1; Phase2 Interventional Servier · NCT06116136

This study is testing a new treatment combining S095029 with pembrolizumab to see if it helps people with advanced gastric cancers that have certain genetic features.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment32 (estimated)
Ages18 Years and up
SexAll
SponsorServier Industry-sponsored
Drugs / interventionspembrolizumab
Locations49 sites (Ocala, Florida and 48 other locations)
Trial IDNCT06116136 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and effectiveness of S095029, an anti-NKG2A antibody, in combination with pembrolizumab for patients with advanced gastric or gastroesophageal junction cancers that are microsatellite instability-high or have defective mismatch repair. The trial is divided into two phases: a safety lead-in to determine the recommended dose and an expansion phase to assess the anti-tumor activity and safety of the combination therapy. Participants will be closely monitored for treatment response and side effects.

Who should consider this trial

Good fit: Ideal candidates are individuals with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with confirmed MSI-H/dMMR status.

Not a fit: Patients who have received multiple lines of treatment or prior therapies with checkpoint inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastric cancers that are difficult to treat.

How similar studies have performed: Other studies have shown promise with similar combination therapies targeting MSI-H/dMMR cancers, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Ocala, Florida and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MSI-H/dMMR Gastroesophageal-junction CancerMSI-H/dMMR Gastric CancerAnti-NKG2AS095029pembrolizumabMSI-H/dMMRGastric cancerGastroesophageal-junction cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.