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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

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507995-33-00
Acronym
CL1-95029-002
Enrollment
31
Registered
2024-05-08
Start date
2024-05-23
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MSI-H/dMMR Gastric cancer, MSI-H/dMMR Gastroesophageal-junction Cancer

Brief summary

Phase 1b and Phase 2: Incidence of dose-limiting toxicities (DLTs)., Phase 1b and Phase 2: Frequency and severity of adverse events (AEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)., Phase 1b and Phase 2: Incidence of AEs leading to dose interruption, modification, delays and permanent treatment discontinuation., Phase 1b and Phase 2: Change from baseline to the end of the study in safety laboratory values and vital signs., Phase 2: Objective response (OR) per investigator assessment using RECIST v1.1.

Detailed description

Phase 1b: Objective response (OR), duration of response (DoR), progression-free survival (PFS), and disease control (DC) according to RECIST v1.1 and iRECIST as assessed by investigator., Phase 1b and Phase 2: Overall survival (OS) per investigator assessment., Phase 1b and Phase 2: Serum concentrations of S095029, Phase 1b and Phase 2: Concentration of potential antibodies directed against S095029., Phase 2: DoR, PFS, and DC according to RECIST v1.1 as assessed by investigator., Phase 2: OR, DoR, PFS, and DC according to iRECIST criteria as per investigator assessment.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Institut De Recherches Internationales Servier IRIS
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase 1b and Phase 2: Incidence of dose-limiting toxicities (DLTs)., Phase 1b and Phase 2: Frequency and severity of adverse events (AEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)., Phase 1b and Phase 2: Incidence of AEs leading to dose interruption, modification, delays and permanent treatment discontinuation., Phase 1b and Phase 2: Change from baseline to the end of the study in safety laboratory values and vital signs., Phase 2: Objective response (OR) per investigator assessment using RECIST v1.1.

Secondary

MeasureTime frame
Phase 1b: Objective response (OR), duration of response (DoR), progression-free survival (PFS), and disease control (DC) according to RECIST v1.1 and iRECIST as assessed by investigator., Phase 1b and Phase 2: Overall survival (OS) per investigator assessment., Phase 1b and Phase 2: Serum concentrations of S095029, Phase 1b and Phase 2: Concentration of potential antibodies directed against S095029., Phase 2: DoR, PFS, and DC according to RECIST v1.1 as assessed by investigator., Phase 2: OR, DoR, PFS, and DC according to iRECIST criteria as per investigator assessment.

Countries

Austria, Belgium, Denmark, France, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026