Last updated 9 days ago
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
32 patients around the world
Available in Puerto Rico, Brazil
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.
Servier Bio-Innovation LLC
6Research sites
32Patients around the world
This study is for people with
Gastroesophageal cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Have a confirmed diagnosis of locally advanced and unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma.Participants' tumor must have an MSI-H or 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.
Sites
Centro Pesquisas Oncologicas - CEPON
Supera Centro de Oncologia e Mastologia
Recruiting
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de Controle do Cancer - IBC
Hospital Israelita Albert Einstein - Fortaleza, Ceara
Pan American Center for Oncology Trials
Recruiting
SponsorServier Bio-Innovation LLC
Conditions
Gastroesophageal cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06116136
