Clinical trial NCT06116136: A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: MSI-H/dMMR Gastroesophageal-junction Cancer
MSI-H/dMMR Gastric Cancer
Keywords: Anti-NKG2A
S095029
pembrolizumab
MSI-H/dMMR
Gastric cancer
Gastroesophageal-junction cancer
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
name: Institut de Recherches Internationales Servier
First posted: 2023-11-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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/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.

Primary outcomes:
measure: Number of Dose-Limiting Toxicities (DLTs)
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Total Number of Adverse Events (AEs)
timeFrame: From screening to 90 days after the last dose
measure: Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
timeFrame: From screening to 90 days after the last dose
measure: Adverse Events (AEs) Leading to Dose Discontinuation
timeFrame: From screening to 90 days after the last dose
measure: Objective Response Rate (ORR)
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: Approximately 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 2 years
measure: Disease Control Rate (DCR)
timeFrame: Approximately 2 years
measure: Overall Survival (OS)
timeFrame: Approximately 2 years
measure: Trough Concentrations of S095029 (Ctrough)
timeFrame: From first dose to 30 days after the last dose
measure: Concentration of potential antibodies directed against S095029
timeFrame: From screening to 30 days after the last dose, or end of study if clinically indicated
measure: Objective Response Rate (ORR)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Ocala Oncology Center Pl
state: Florida
city: Noblesville
country: United States
facility: Investigative Clinical Research of Indiana, Llc
state: Indiana
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
city: Linz
country: Austria
facility: Ordensklinikum Linz
city: Salzburg
country: Austria
facility: Landeskrankenhaus (SALK)
city: Wien
country: Austria
facility: Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)
city: Leuven
country: Belgium
facility: UZ Leuven Campus Gasthuisberg
city: Liège
country: Belgium
facility: Chu de Liege
city: Florianópolis
country: Brazil
facility: Cepon - Centro de Pesquisas Oncologicas
city: Santa Catarina
country: Brazil
facility: Supera Oncologia
city: Sao Paulo
country: Brazil
facility: Icesp - Instituto Do Câncer Do Estado de São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto Brasileiro de Controle Do Câncer
city: Sao Paulo
country: Brazil
facility: Hospital Albert Einstein
city: Toronto
country: Canada
facility: Mount Sinai Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital Institute
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine Qingchun Branch
state: Zhengjiang Province
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Bordeaux
country: France
facility: Institut Bergonié
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Lille
country: France
facility: Chru Lille - Hopital Claude Huriez
city: Saint Herblain
country: France
facility: Inst. de Cancer de L'ouest
city: Saint-Cloud
country: France
facility: Institut Curie
city: Vandoeuvre-les-Nancy Cedex
country: France
facility: Institut de Cancerologie de Lorraine
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Gyöngyös
country: Hungary
facility: Bugat Pal Hospital
city: Campania
country: Italy
facility: A.O.U. Seconda Università Degli Studi Di Napoli
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumor
city: Pisa
country: Italy
facility: A.O.U. Pisana-Ospedale Santa Chiara
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Verona
country: Italy
facility: Policlinico G.B. Rossi A.O.U.I. Di Verona
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of Jfcr
state: Tokyo
city: Chou-ku
country: Japan
facility: National Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center For Oncology Trials, Llc
city: Barcelona
country: Spain
facility: University Hospital Vall D'Hebron Institute of Oncology (VHIO)
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Universitario de Valencia
city: London
country: United Kingdom
facility: The Royal Marsden in Chelsea
city: Sutton, Surrey
country: United Kingdom
facility: The Royal Marsden in Sutton
Study officials:
References: