Trial Title:
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
NCT ID:
NCT06116136
Condition:
MSI-H/dMMR Gastroesophageal-junction Cancer
MSI-H/dMMR Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Pembrolizumab
Conditions: Keywords:
Anti-NKG2A
S095029
pembrolizumab
MSI-H/dMMR
Gastric cancer
Gastroesophageal-junction cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
S095029
Description:
Participants will be treated with S095029 via intravenous (IV) infusion every 3 weeks
(Q3W).
Arm group label:
S095029 and pembrolizumab
Intervention type:
Drug
Intervention name:
pembrolizumab 200 mg (KEYTRUDA ®)
Description:
Participants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion
every 3 weeks (Q3W).
Arm group label:
S095029 and pembrolizumab
Summary:
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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 or 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
The Queen Elisabeth Hospital
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Recruiting
Facility:
Name:
Ordensklinikum Linz
Address:
City:
Linz
Zip:
04010
Country:
Austria
Status:
Recruiting
Facility:
Name:
Landeskrankenhaus (SALK)
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)
Address:
City:
Wien
Zip:
01090
Country:
Austria
Status:
Recruiting
Facility:
Name:
UZ Leuven Campus Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Chu de Liege
Address:
City:
Liège
Zip:
04000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Odense Universitetshospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Inst. de Cancer de L'ouest
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
Saint-Cloud
Zip:
92064
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Bugat Pal Hospital
Address:
City:
Gyöngyös
Zip:
3200
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumor
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
A.O.U. Pisana-Ospedale Santa Chiara
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico Universitario Agostino Gemelli
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico G.B. Rossi A.O.U.I. Di Verona
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Facility:
Name:
University Hospital Val De Hebron Institute of Oncology (VHIO)
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Gregorio Marañón
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Marqués de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Start date:
August 31, 2024
Completion date:
June 1, 2029
Lead sponsor:
Agency:
Servier Bio-Innovation LLC
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Collaborator:
Agency:
Institut de Recherches Internationales Servier
Agency class:
Other
Source:
Servier
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116136
