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

Servier

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: MSI-H/dMMR Gastroesophageal-junction Cancer; MSI-H/dMMR Gastric Cancer

Treatments: Drug: S095029; Drug: pembrolizumab 200 mg (KEYTRUDA ®)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06116136

MK-3475-E70 (Other Identifier)

CL1-95029-002

2023-507995-33 (EudraCT Number)

Keynote E70 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

S095029 and pembrolizumab

Experimental group

Description:

Participants diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJ), not previously treated with checkpoint inhibitors (CPIs) may first be enrolled into a Phase 1b safety lead-in part which will be used to identify the recommended Phase 2 dose (RP2D) of S095029 in combination with pembrolizumab. During the Phase 2 part, participants will receive the recommended Phase 2 dose (RP2D) of S095029, along with pembrolizumab.

Treatment:

Drug: pembrolizumab 200 mg (KEYTRUDA ®)

Drug: S095029