A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
Sponsor: Servier Bio-Innovation LLC
ClinicalTrials ID:NCT06116136
This Phase 1b/2 study assesses the safety and antitumor activity of S095029 with pembrolizumab in MSI-H/dMMR gastric/GEJ adenocarcinomas. Eligible participants have locally advanced unresectable or metastatic tumors. S095029 and pembrolizumab are administered via IV infusion every 3 weeks.
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Program Overview
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.
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.
Eligibility 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 or 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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