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Subcutaneous versus intravenous tislelizumab with chemotherapy for unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma

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

Phase 3 Interventional BeOne Medicines · NCT07043400

This will test whether giving tislelizumab as a subcutaneous injection instead of an IV infusion, both with chemotherapy, works well and is safe as first treatment for adults with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment351 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Drugs / interventionstislelizumab
Locations86 sites (Chandler, Arizona and 85 other locations)
Trial IDNCT07043400 on ClinicalTrials.gov

What this trial studies

This phase 3 trial compares subcutaneous (SC) versus intravenous (IV) administration of the PD‑1 antibody tislelizumab, each given with standard chemotherapy (cisplatin, leucovorin, and 5‑fluorouracil), as first‑line therapy for adults with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Approximately 351 patients will undergo screening, receive assigned treatment during a defined treatment period, and be followed for safety and outcomes. The primary focus is on systemic drug exposure and pharmacokinetics after SC versus IV dosing, with tumor tissue collection for biomarker analyses and response assessment by RECIST v1.1. Eligibility requires ECOG 0–1, adequate organ function, and availability of tumor tissue.

Who should consider this trial

Good fit: Adults with histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior systemic therapy, have ECOG performance status 0–1, and can provide tumor tissue are the ideal candidates.

Not a fit: Patients with non‑adenocarcinoma histology (for example squamous or undifferentiated gastric cancer), active leptomeningeal disease, or those unable to receive cisplatin/5‑FU chemotherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, a subcutaneous formulation could provide comparable exposure and effectiveness while making dosing faster, more convenient, and less resource‑intensive than IV infusion.

How similar studies have performed: Early work with IV tislelizumab and other PD‑1 inhibitors is established, and preliminary studies of subcutaneous PD‑1 formulations have shown comparable drug exposure and added convenience, but larger phase 3 data for SC tislelizumab in this indication are still being generated.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Chandler, Arizona and 85 other locations

+36 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.