Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Servier Bio-Innovation LLC (Voir sur ClinicalTrials)
août 2024
juin 2029
04 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:11:54 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges Francois Leclerc - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Chru Lille - Hopital Claude Huriez - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Inst. de Cancer de L'ouest - 44805 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de Lorraine - 54519 - Vandoeuvre-les-Nancy Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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/dMMR status according to institutional
guidelines and/or according to the College of American Pathologists, determined at
any time prior to enrolment.
- 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.
- 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.