A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
Running, not enrolling · Phase 1/Phase 2
Conditions studied: MSI-H/dMMR Gastroesophageal-junction Cancer, MSI-H/dMMR Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT06116136
- Run by
- Servier Bio-Innovation LLC
- People needed
- 48
- Starts
- 2024-08-31
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a confirmed diagnosis of locally advanced and unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
- Participants' tumor must have an MSI-H/dMMR status according to institutional guidelines and/or according to the College of American Pathologists, determined at any time prior to enrolment.
You may not qualify if…
- 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.
Where it is running
- Ocala Oncology Center Pl — Ocala, Florida, United States
- Investigative Clinical Research of Indiana, Llc — Noblesville, Indiana, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- The Queen Elizabeth Hospital — Woodville South, Australia
- Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH) — Vienna, State of Vienna, Austria
- Ordensklinikum Linz — Linz, Upper Austria, Austria
- Landeskrankenhaus (SALK) — Salzburg, Austria
- UZ Leuven Campus Gasthuisberg — Leuven, Belgium
- Chu de Liege — Liège, Belgium
- Cepon - Centro de Pesquisas Oncologicas — Florianópolis, Brazil
- Supera Oncologia — Santa Catarina, Brazil
- Icesp - Instituto Do Câncer Do Estado de São Paulo — São Paulo, Brazil
- Instituto Brasileiro de Controle Do Câncer — São Paulo, Brazil
- Hospital Albert Einstein — São Paulo, Brazil
- Mount Sinai Hospital — Toronto, Canada
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
- Henan Cancer Hospital — Zhengzhou, Henan, China
- Liaoning Cancer Hospital — Shenyang, Liaoning, China
- Shandong Cancer Hospital Institute — Jinan, Shandong, China
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch — Hangzhou, Zhengjiang Province, China
- Rigshospitalet — Copenhagen, Denmark
- Odense Universitetshospital — Odense, Denmark
- Institut Bergonié — Bordeaux, France
Full record on ClinicalTrials.gov
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