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

Condition(s) studied

Investigational drug(s) / intervention(s)

S095029: Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).

pembrolizumab 200 mg (KEYTRUDA ®): Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of Dose-Limiting Toxicities (DLTs) — At the end of Cycle 1 (each cycle is 21 days)
  Phase 1b and Phase 2
• Total Number of Adverse Events (AEs) — From screening to 90 days after the last dose
  Phase 1b and Phase 2
• Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays — From screening to 90 days after the last dose
  Phase 1b and Phase 2
• Adverse Events (AEs) Leading to Dose Discontinuation — From screening to 90 days after the last dose
  Phase 1b and Phase 2
• Objective Response Rate (ORR) — 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.

Trial sites (49)

+ 9 more sites — see the full list on the official registry below.

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