NCT07043400 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
| NCT ID | NCT07043400 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | BeOne Medicines |
| Condition | Metastatic Gastric Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 351 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 351 participants in total. It began in 2025-08-27 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Study Director
STUDY DIRECTOR
BeOne Medicines
Frequently Asked Questions
Who can join the NCT07043400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Gastric Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07043400 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 351 participants.
Is NCT07043400 currently recruiting?
Yes, NCT07043400 is actively recruiting participants. Contact the research team at clinicaltrials@beonemed.com for enrollment information.
Where is the NCT07043400 trial being conducted?
This trial is being conducted at Chandler, United States, Los Alamitos, United States, Colorado Springs, United States, Hialeah, United States and 11 additional locations.
Who is sponsoring the NCT07043400 clinical trial?
NCT07043400 is sponsored by BeOne Medicines. The principal investigator is Study Director at BeOne Medicines. The trial plans to enroll 351 participants.