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Active, Not Recruiting

NCT Number: NCT06116136

A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Queen Elizabeth Hospital, Woodville South, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S095029

Drug

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).

Primary outcomes

  1. Number of Dose-Limiting Toxicities (DLTs)

    Time frame: At the end of Cycle 1 (each cycle is 21 days)

    Phase 1b and Phase 2

  2. Total Number of Adverse Events (AEs)

    Time frame: From screening to 90 days after the last dose

    Phase 1b and Phase 2

  3. 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

  4. Adverse Events (AEs) Leading to Dose Discontinuation

    Time frame: From screening to 90 days after the last dose

    Phase 1b and Phase 2

  5. 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.

Secondary outcomes

  1. Duration of Response (DoR)

    Time frame: Approximately 2 years

    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).

  2. Progression-Free Survival (PFS)

    Time frame: Approximately 2 years

    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).

  3. Disease Control Rate (DCR)

    Time frame: Approximately 2 years

    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).

  4. Overall Survival (OS)

    Time frame: Approximately 2 years

    Phase 1b and Phase 2. The time from first S095029 dose to death due to any cause.

  5. Trough Concentrations of S095029 (Ctrough)

    Time frame: From first dose to 30 days after the last dose

    Phase 1b and Phase 2.

  6. 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

    Phase 1b and Phase 2.

  7. Objective Response Rate (ORR)

    Time frame: Approximately 2 years

    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).

Sponsors and collaborators

Lead sponsor

Servier Bio-Innovation LLC

Industry

Collaborators

  • Institut de Recherches Internationales Servier
  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 3, 2023
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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