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AzTrials

Metastatic Gastric AdenocarcinomaPhase 3NCT07043400

A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 3 study testing Subcutaneous Tislelizumab, Intravenous Tislelizumab and Cisplatin in people with Metastatic Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by BeOne Medicines at 95 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Subcutaneous Tislelizumab, Intravenous Tislelizumab and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
95 sitesin 16 countries
Study dates
27 Aug 2025to 22 Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma.
  • No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
  • At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.
  • Must be able to provide tumor tissues for biomarker assessment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.
  • Adequate organ function.
  • 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.
  • 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.

Who cannot join

  • Squamous cell or undifferentiated or other histological type gastric cancer (GC)
  • 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.
  • Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).
  • Active autoimmune diseases or history of autoimmune diseases that may relapse.
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

95 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

BeOne Medicines contact

1-877-828-5568

clinicaltrials@beonemed.com

95 sites in 16 countries

United States19 sites, 19 recruiting

  • St Louis Cancer Care, Llp

    Bridgeton, Missouri, 63044

    Recruiting

  • Ironwood Cancer and Research Centers Chandler Ii

    Chandler, Arizona, 85224-5665

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Recruiting

  • UC Health Cancer Care and Hematology Clinic Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Recruiting

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822-4603

    Recruiting

  • Summit Medical Group

    Florham Park, New Jersey, 07932-1049

    Recruiting

  • Bioresearch Partners Holding Hialeah Hospital

    Hialeah, Florida, 33013-3804

    Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521-0509

    Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

    Recruiting

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160-8500

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169-3321

    Recruiting

  • Nebraska Hematology Oncology

    Lincoln, Nebraska, 68506-7548

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, 37232

    Recruiting

  • Orlando Health Cancer Institute Downtown Orlando

    Orlando, Florida, 32806

    Recruiting

  • Oregon Oncology Specialists

    Salem, Oregon, 97301

    Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

    Recruiting

  • Baylor Scott and White Medical Center Temple

    Temple, Texas, 76508-0001

    Recruiting

  • New England Cancer Specialists

    Westbrook, Maine, 04092

    Recruiting

Other trials in United States

China15 sites, 15 recruiting

  • Anyang Tumor Hospital

    Anyang, Henan, 455001

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Recruiting

  • Changzhi Peoples Hospital

    Changzhi, Shanxi, 046099

    Recruiting

  • Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University

    Ganzhou, Jiangxi, 341000

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

    Recruiting

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

Brazil11 sites, 11 recruiting

  • Hospital de Amor Barretos

    Barretos, 14784-400

    Recruiting

  • CECAP

    Blumenau, 89035-510

    Recruiting

  • Hospital Brasilia

    Brasília, 71681-603

    Recruiting

  • Hospital Universiario Onofre Lopes

    Natal, 59012-300

    Recruiting

  • Hospital Sao Lucas Da Pucrs

    Porto Alegre, 90610-000

    Recruiting

  • IMIP

    Recife, 50070-902

    Recruiting

  • Inca Instituto Nacional de Cancer

    Rio de Janeiro, 20231-050

    Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, 15090-000

    Recruiting

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    São Paulo, 01246-000

    Recruiting

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    São Paulo, 01401-004

    Recruiting

  • Hospital Santa Rita de Cassia Afecc

    Vitória, 29043-260

    Recruiting

Other trials in Brazil

Japan10 sites, 9 recruiting

  • Institute of Science Tokyo Hospital

    Bunkyoku, Tokyo, 113-8519

    Recruiting

  • Hamamatsu University School of Medicine, University Hospital

    Hamamatsushi, Shizuoka, 431-3192

    Recruiting

  • Saitama Cancer Center

    Kitaadachigun, Saitama, 362-0806

    Recruiting

  • Japan Community Health Care Organization Kyushu Hospital

    Kitakyushu, Fukuoka, 806-0034

    Recruiting

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime, 790 8524

    Recruiting

  • Osaka Rosai Hospital

    SakaiShi, Osaka, 591-8025

    Recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

    Recruiting

  • Tokyo Metropolitan Bokutoh Hospital

    SumidaKu, Tokyo, 130-8575

    Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsukishi, Osaka, 569-8686

    Recruiting

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

    Active, not recruiting

Other trials in Japan

South Korea6 sites

  • Kyungpook National University Chilgok Hospital

    BukGu, Gyeongsangbukdo, 41404

    Active, not recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

    Active, not recruiting

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

    Active, not recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Active, not recruiting

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

    Active, not recruiting

Other trials in South Korea

Czechia4 sites, 4 recruiting

  • Masarykuv Onkologicky Ustav

    Brno, 602 00

    Recruiting

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 03

    Recruiting

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900

    Recruiting

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000

    Recruiting

Other trials in Czechia

Italy4 sites, 4 recruiting

  • Irccs Azienda Ospedaliera Metropolitana (Aom)

    Genova, 16132

    Recruiting

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133

    Recruiting

  • Aou Pisana, Stabilimento Di Santa Chiara

    Pisa, 56126

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

Other trials in Italy

Spain4 sites, 4 recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Turkey (Türkiye)4 sites, 4 recruiting

  • Medical Park Seyhan Hospital

    Adana, 01060

    Recruiting

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200

    Recruiting

  • Acibadem Adana Hospital

    Kuruköprü, 01060

    Recruiting

  • Medical Park Florya Hospital

    Sefaköy, 34295

    Recruiting

Other trials in Turkey (Türkiye)

Argentina3 sites, 3 recruiting

  • Hospital Aleman

    Caba, 1425

    Recruiting

  • Instituto Alexander Fleming (Iaf)

    Ciudad Autonoma Buenos Aires, 1426

    Recruiting

  • Fundacion Cori Para La Investigacion Y Prevencion Del Cancer

    La Rioja, F5300COE

    Recruiting

Other trials in Argentina

France3 sites, 3 recruiting

  • Institut Sainte Catherine

    Avignon, 84000

    Recruiting

  • Chru de Brest Hopital Cavale Blanche

    Brest, 29200

    Recruiting

  • Hopital Claude Huriez Chu Lille

    Lille, 59000

    Recruiting

Other trials in France

Mexico3 sites, 3 recruiting

  • Medical Care and Research Sa de Cv

    Mérida, 97070

    Recruiting

  • Health Pharma Professional Research Sa de Cv

    Mexico City, 03100

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

    Recruiting

Other trials in Mexico

Poland3 sites, 3 recruiting

  • Pratia McM Krakow

    Krakow, 30-727

    Recruiting

  • Opolskie Centrum Onkologii

    Opole, 45-061

    Recruiting

  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie

    Warsaw, 02-781

    Recruiting

Other trials in Poland

United Kingdom3 sites, 3 recruiting

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ

    Recruiting

  • Ninewells Hospital and Medical School

    Dundee, DD1 9SY

    Recruiting

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

    Recruiting

Other trials in United Kingdom

Austria2 sites, 2 recruiting

  • Krankenhaus Der Barmherzigen Schwestern Linz

    Linz, 4010

    Recruiting

  • Medical Univeristy Vienna

    Vienna, 1090

    Recruiting

Other trials in Austria

Puerto Rico1 site, 1 recruiting

  • Pan American Oncology Trials, Llc

    Rio Piedras, 00935

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.

Read the detailed description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Being tested
Subcutaneous Tislelizumab, Intravenous Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil (5-FU)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcutaneous TislelizumabDrug

    Also called BGB-A317

    Administered by subcutaneous injection

  • Intravenous TislelizumabDrug

    Also called BGB-A317, TEVIMBRA®

    Administered by intravenous infusion

  • CisplatinDrug

    Administered by intravenous infusion

  • LeucovorinDrug

    Administered by intravenous infusion

  • 5-fluorouracil (5-FU)Drug

    Administered by intravenous infusion

  • OxaliplatinDrug

    Administered by intravenous infusion

  • CapecitabineDrug

    Administered orally

Study groups in NCT07043400
Study groupRoleWhat they receive
Arm A: Tislelizumab Subcutaneous + ChemotherapyExperimentalParticipants will receive tislelizumab 300 mg subcutaneous (SC) injection on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.
Receives: Drug: Subcutaneous Tislelizumab; Drug: Cisplatin; Drug: Leucovorin; Drug: 5-fluorouracil (5-FU); Drug: Oxaliplatin; Drug: Capecitabine
Arm B: Tislelizumab Intravenous Infusion + ChemotherapyActive comparatorParticipants will receive tislelizumab 200 mg intravenous infusion (IV) on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.
Receives: Drug: Intravenous Tislelizumab; Drug: Cisplatin; Drug: Leucovorin; Drug: 5-fluorouracil (5-FU); Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab

    Measured: 85 Days

  2. Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab

    Measured: 21 Days

Secondary outcomes (11)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 2 years

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization date until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1

    Measured: Up to 2 years

  3. Duration of Response (DOR)

    DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as assessed by the investigator using RECIST v1.1

    Measured: Up to 2 years

  4. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1

    Measured: Up to 2 years

  5. Overall Survival (OS)

    OS is defined as the time from first study drug administration to the date of death due to any cause

    Measured: Up to 2 years

  6. Number of Participants With Adverse Events (AEs)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.

    Measured: Up to 2 years

  7. Model-predicted Serum Ctrough at Cycle 1

    Measured: 21 Days

  8. Observed Serum Ctrough at Cycle 1

    Measured: 21 Days

  9. Observed Area Under the Concentration-time Curve at Steady-state (AUC) at Cycle 1

    Measured: 21 Days

  10. Model-predicted Area Under the Concentration-time Curve at Steady-state (AUCss)

    Measured: 85 Days

  11. Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab after SC or IV Administration

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2025
  2. Study start27 Aug 2025
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion22 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
351 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07043400
Sponsor's protocol ID
BGB-A317-316
Other IDs
2025-522862-58-00, 2025
Status last verified
Sep 2026
First submitted
20 Jun 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Subcutaneous Tislelizumab, Intravenous Tislelizumab and Cisplatin in people with Metastatic Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by BeOne Medicines at 95 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, China, Brazil, Japan, South Korea and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BeOne Medicines (1-877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab (time frame: 85 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07043400.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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