A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
Phase 1/2 – combined early trial
Conditions:
MSI-H/dMMR Gastroesophageal-junction Cancer
MSI-H/dMMR Gastric Cancer
Sponsor: Servier Bio-Innovation LLC
trial.available_in:
БГ
Overview
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.
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.
Who can participate
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.
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.
Locations
14
Australia (1)
The Queen Elizabeth Hospital
Woodville South
Belgium (1)
UZ Leuven Campus Gasthuisberg
Leuven
Brazil (1)
Cepon - Centro de Pesquisas Oncologicas
Florianópolis
Canada (1)
Mount Sinai Hospital
Toronto
China (1)
Beijing Cancer Hospital
Beijing , Beijing Municipality
Denmark (1)
Rigshospitalet
Copenhagen
France (1)
Institut Bergonié
Bordeaux
Hungary (1)
Semmelweis Egyetem
Budapest
Italy (1)
A.O.U. Seconda Università Degli Studi Di Napoli
Campania
Japan (1)
Cancer Institute Hospital of Jfcr
Koto-Ku , Tokyo
Puerto Rico (1)
Pan American Center For Oncology Trials, Llc
Rio Piedras
Spain (1)
University Hospital Vall D'Hebron Institute of Oncology (VHIO)