Clinical trial • Phase III • Oncology|Gastroenterology|Other
TISLELIZUMAB for Gastric adenocarcinoma|Gastroesophageal junction adenocarcinoma
Phase III trial of TISLELIZUMAB for Gastric adenocarcinoma|Gastroesophageal junction adenocarcinoma.
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology|Other
- Trial Disease
- Gastric adenocarcinoma|Gastroesophageal junction adenocarcinoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 18-07-2025
- First CTIS Authorization Date
- 10-11-2025
Trial design
Randomised, open-label, tevimbra 100 mg concentrate for solution for infusion (tislelizumab iv; product name tevimbra; marketing authorisation eu/1/23/1758/001; route: intravenous administration; max daily dose amount reported 200 mg) administered plus chemotherapy (as described in trial title).-controlled Phase III trial in Austria, Italy, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Tevimbra 100 mg concentrate for solution for infusion (tislelizumab IV; product name Tevimbra; marketing authorisation EU/1/23/1758/001; route: intravenous administration; max daily dose amount reported 200 mg) administered plus chemotherapy (as described in trial title).
- Target Sample Size
- 288
Eligibility
Recruits 288 No vulnerable population selected (isVulnerablePopulationSelected=false). Trial population limited to adults; standard informed consent processes apply; assent not applicable..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Trial population limited to adults; standard informed consent processes apply; assent not applicable.
Inclusion criteria
- {"criterion_text":"- Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma."}
- {"criterion_text":"- No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer."}
- {"criterion_text":"- At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment."}
- {"criterion_text":"- Must be able to provide tumor tissues for biomarker assessment."}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1."}
- {"criterion_text":"- Adequate organ function."}
- {"criterion_text":"- Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab."}
- {"criterion_text":"- Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab."}
Exclusion criteria
- {"criterion_text":"- Squamous cell or undifferentiated or other histological type gastric cancer (GC)."}
- {"criterion_text":"- Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization."}
- {"criterion_text":"- Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2)."}
- {"criterion_text":"- Active autoimmune diseases or history of autoimmune diseases that may relapse."}
- {"criterion_text":"- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Model-predicted trough serum concentration (Ctrough) at steady-state (predose C5D1) and model-predicted AUC0-21d of Cycle 1","definition_or_measurement_approach":"Model-predicted pharmacokinetic parameters: trough serum concentration (Ctrough) at steady-state (predose C5D1) and model-predicted AUC0-21d in Cycle 1."}
Secondary endpoints
- {"endpoint_text":"- Overall response rate (ORR), progression-free survival (PFS), duration of response (DOR), and disease control rate (DCR) each assessed by investigator per RECIST v1.1, and overall survival (OS)","definition_or_measurement_approach":"Efficacy endpoints assessed by investigator per RECIST v1.1 (ORR, PFS, DOR, DCR) and overall survival (OS)."}
- {"endpoint_text":"- Adverse events (AE) and serious adverse events (SAE) as characterized by type, frequency, severity (NCI-CTCAE v5.0), timing, seriousness, and relationship to study treatment","definition_or_measurement_approach":"Safety endpoints characterized by AE/SAE type, frequency, severity (NCI-CTCAE v5.0), timing, seriousness, and relationship to treatment."}
- {"endpoint_text":"- Model-predicted and observed Cycle 1 Ctrough, observed Cycle 1 AUC, and model-predicted AUC at steady-state (AUCss)","definition_or_measurement_approach":"Pharmacokinetic endpoints including observed and model-predicted Cycle 1 Ctrough and AUC, and model-predicted steady-state AUC (AUCss)."}
- {"endpoint_text":"- Percentage of patients with antidrug antibodies (ADAs) to tislelizumab after subcutaneous (SC) or intravenous (IV) administration","definition_or_measurement_approach":"Immunogenicity measured as percentage of patients with antidrug antibodies (ADA) after SC or IV administration."}
Recruitment
- Planned Sample Size
- 288
- Recruitment Window Months
- 28
- Consent Approach
- Informed consent obtained using subject information and informed consent forms (ICFs). Multiple ICF and patient information documents are provided (including language-specific versions). Specific ICFs include pregnancy/pregnant partner information and optional storage/future research consent documents.
Geography
- Total Number Of Sites
- 20
- Total Number Of Participants
- 63
Austria
- Earliest CTIS Part Ii Submission Date
- 27-10-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 179
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Department Internal I
- Principal Investigator Name
- Bernhard Doleschal
- Principal Investigator Email
- bernhard.doleschal@ordensklinikum.at
- Contact Person Name
- Bernhard Doleschal
- Contact Person Email
- bernhard.doleschal@ordensklinikum.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Internal Medicine I
- Principal Investigator Name
- Aysegül Ilhan-Mutlu
- Principal Investigator Email
- aysegul.ilhan@meduniwien.ac.at
- Contact Person Name
- Aysegül Ilhan-Mutlu
- Contact Person Email
- aysegul.ilhan@meduniwien.ac.at
Italy
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 257
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology Division 1
- Principal Investigator Name
- Filippo Pietrantonio
- Principal Investigator Email
- filippo.pietrantonio@istitutotumori.mi.it
- Contact Person Name
- Filippo Pietrantonio
- Contact Person Email
- filippo.pietrantonio@istitutotumori.mi.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncology and Hematology Unit
- Principal Investigator Name
- Alberto Puccini
- Principal Investigator Email
- alberto.puccini@cancercenter.humanitas.it
- Contact Person Name
- Alberto Puccini
- Contact Person Email
- alberto.puccini@cancercenter.humanitas.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Divisione Ematologia Centro Trapianti di Midollo
- Principal Investigator Name
- Anna Maria Pessino
- Principal Investigator Email
- annamaria.pessino@hsanmartino.it
- Contact Person Name
- Anna Maria Pessino
- Contact Person Email
- annamaria.pessino@hsanmartino.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- U.O. Oncologia Medica 2
- Principal Investigator Name
- Lorenzo Fornaro
- Principal Investigator Email
- lorenzo.fornaro@gmail.com
- Contact Person Name
- Lorenzo Fornaro
- Contact Person Email
- lorenzo.fornaro@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 01-10-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 208
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Anne Ploquin
- Principal Investigator Email
- xxxxxx@xxxxxxx.fr
- Contact Person Name
- Anne Ploquin
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Oncologie
- Principal Investigator Name
- Jean- Philippe METGES
- Principal Investigator Email
- xxxxxx@xxxxxxx.fr
- Contact Person Name
- Jean- Philippe METGES
- Contact Person Email
- xxxxxx@xxxxxxx.fr
- Site Name
- Sainte Catherine Institut Du Cancer Avignon-Provence
- Department Name
- Oncologie -radiotherapie
- Principal Investigator Name
- Laurent Mineur
- Principal Investigator Email
- xxxxxx@xxxxxxx.fr
- Contact Person Name
- Laurent Mineur
- Contact Person Email
- xxxxxx@xxxxxxx.fr
Czechia
- Earliest CTIS Part Ii Submission Date
- 28-10-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 175
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Oncology clinic
- Principal Investigator Name
- Michal Vočka
- Principal Investigator Email
- michal.vocka@vfn.cz
- Contact Person Name
- Michal Vočka
- Contact Person Email
- michal.vocka@vfn.cz
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Clinic of Comprehensive cancer Care
- Principal Investigator Name
- Radka Obermannová
- Principal Investigator Email
- radka.obermannova@mou.cz
- Contact Person Name
- Radka Obermannová
- Contact Person Email
- radka.obermannova@mou.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Department of Oncology and Radiotherapy
- Principal Investigator Name
- Milan Vošmik
- Principal Investigator Email
- milan.vosmik@fnhk.cz
- Contact Person Name
- Milan Vošmik
- Contact Person Email
- milan.vosmik@fnhk.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Department of Oncology
- Principal Investigator Name
- Bohuslav Melichar
- Principal Investigator Email
- Bohuslav.Melichar@fnol.cz
- Contact Person Name
- Bohuslav Melichar
- Contact Person Email
- Bohuslav.Melichar@fnol.cz
Poland
- Earliest CTIS Part Ii Submission Date
- 01-10-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 205
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- -
- Principal Investigator Name
- Lucjan Wyrwicz
- Principal Investigator Email
- lucjan.wyrwicz@nio.gov.pl
- Contact Person Name
- Lucjan Wyrwicz
- Contact Person Email
- lucjan.wyrwicz@nio.gov.pl
- Site Name
- Klinika Onkologii z Odcinkiem Dziennym, SPZOZ Opolskie Centrum Onkologii
- Department Name
- Klinika Onkologii z Odcinkiem Dziennym
- Principal Investigator Name
- Barbara Radecka
- Principal Investigator Email
- badaniakliniczne@onkologia.opole.pl
- Contact Person Name
- Barbara Radecka
- Contact Person Email
- badaniakliniczne@onkologia.opole.pl
- Site Name
- PRATIA MCM Kraków
- Department Name
- -
- Principal Investigator Name
- Anna Drosik-Kwasniewska
- Principal Investigator Email
- rejestracja.mcm@pratia.com
- Contact Person Name
- Anna Drosik-Kwasniewska
- Contact Person Email
- rejestracja.mcm@pratia.com
Spain
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 259
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Tamara Sauri Nadal
- Principal Investigator Email
- sauri@clinic.cat
- Contact Person Name
- Tamara Sauri Nadal
- Contact Person Email
- sauri@clinic.cat
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- María Alsina Maqueda
- Principal Investigator Email
- maria.alsina.maqueda@navarra.es
- Contact Person Name
- María Alsina Maqueda
- Contact Person Email
- maria.alsina.maqueda@navarra.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Tania Fleitas Kanonnikoff
- Principal Investigator Email
- tfleitas@incliva.es
- Contact Person Name
- Tania Fleitas Kanonnikoff
- Contact Person Email
- tfleitas@incliva.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Oncology
- Principal Investigator Name
- Roberto Pazo Cid
- Principal Investigator Email
- rpazo@salud.aragon.es
- Contact Person Name
- Roberto Pazo Cid
- Contact Person Email
- rpazo@salud.aragon.es
Sponsor
Primary sponsor
- Full Name
- BeOne Medicines AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties codes: 8
- Name
- Iqvia Laboratories Limited
- Responsibilities
- sponsorDuties codes: 4
- Name
- Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
- Responsibilities
- sponsorDuties codes: 4
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- sponsorDuties codes: 3
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties codes: 7
Third parties
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: 15 (Importation of IMP into the EU;)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties codes: 15 (Patient expenses reimbursement)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: 15 (Importation of IMP into the EU;)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Tislelizumab 300 mg solution for injection
- Active Substance
- TISLELIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Investigational product (prodAuthStatus: 1)
- Maximum Dose
- 300 mg (maxDailyDoseAmount 300)
- Investigational Product Name
- Tevimbra 100 mg concentrate for solution for infusion
- Active Substance
- TISLELIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS ADMINISTRATION
- Authorisation Status
- Authorized (marketing authorisation EU/1/23/1758/001; prodAuthStatus: 2)
- Maximum Dose
- 200 mg (maxDailyDoseAmount 200)
- Combination Treatment
- Yes
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