Study on the Safety and Effectiveness of S095029 with Pembrolizumab for Advanced Stomach and Gastroesophageal Junction Cancers

Sponsor: Servier Bio-Innovation LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06116136

Provider View

This clinical trial is testing a new treatment combination of S095029 and pembrolizumab to see if it is safe and effective for patients with advanced stomach or gastroesophageal junction cancers that cannot be removed by surgery.

Patient Parameters

Program Overview

The study aims to find out if a new treatment using S095029, an anti-NKG2A antibody, combined with pembrolizumab, can safely and effectively treat advanced stomach and gastroesophageal junction cancers that have specific genetic features (MSI-H/dMMR). The trial will be conducted in two parts: the first part will focus on determining the safest dose, and the second part will evaluate how well the treatment works in shrinking tumors.

Description

This clinical trial is divided into two phases. In the first phase, researchers will determine the safest dose of S095029 when used with pembrolizumab. This phase is called the safety lead-in phase. In the second phase, the study will expand to include more participants to see how well the treatment works in reducing tumors in patients with advanced stomach or gastroesophageal junction cancers that have specific genetic markers (MSI-H/dMMR). The study will monitor participants for any side effects and assess the overall effectiveness of the treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced stomach or gastroesophageal junction cancer that cannot be removed by surgery or has spread to other parts of the body.
  • The cancer must have specific genetic features known as MSI-H or dMMR, as determined by medical guidelines or tests done before joining the study.

Exclusion Criteria

  • Have received more than one previous treatment for advanced cancer that cannot be removed by surgery or has spread.
  • Have previously been treated with any checkpoint inhibitors, such as anti-PD-1, anti-PDL1, or anti-CTLA4 therapies.
  • Have received any other cancer treatments, including experimental drugs, within four weeks before starting the study treatment.
  • Have had radiation therapy less than two weeks before starting the study treatment.
  • Have had major surgery less than four weeks before starting the study treatment or have not fully recovered from the surgery's side effects.

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