The purpose of this study is to determine whether Tislelizumab, when given as a subcutaneous (SC) injection, reaches the same drug levels in the body as Tislelizumab given intravenously (IV). This study will also assess whether SC Tislelizumab is as safe and effective as the IV version. Tislelizumab IV, when combined with chemotherapy, has already been shown to be effective and safe in patients with metastatic gastric or gastroesophageal junction adenocarcinoma.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

BeOne Medicines AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

9 Jan 2026 → ongoing

Decision date (initial)

2025-11-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

BeOne Medicines Ltd.

External identifiers

EU CT number

2025-522862-58-00

ClinicalTrials.gov

NCT07043400

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety

To demonstrate PK noninferiority of tislelizumab SC compared with tislelizumab IV

Secondary objectives 4

1. To compare efficacy of tislelizumab SC and IV
2. To evaluate the safety and tolerability profile of tislelizumab SC and IV
3. To compare PK of tislelizumab between SC and IV routes of administration
4. To compare immunogenicity of tislelizumab between SC and IV routes of administration

Conditions and MedDRA coding

Locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002480-PIP01-18

Plan to share IPD

Yes

IPD plan description

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 BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma.
2. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
3. At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.
4. Must be able to provide tumor tissues for biomarker assessment.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.
6. Adequate organ function.
7. 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.
8. 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 5

1. Squamous cell or undifferentiated or other histological type gastric cancer (GC).
2. 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.
3. Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).
4. Active autoimmune diseases or history of autoimmune diseases that may relapse.
5. 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 and secondary outcome measures (English text)

Primary endpoints 1

1. Model-predicted trough serum concentration (Ctrough) at steady-state (predose C5D1) and model-predicted AUC0-21d of Cycle 1

Secondary endpoints 4

1. 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)
2. 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
3. Model-predicted and observed Cycle 1 Ctrough, observed Cycle 1 AUC, and model-predicted AUC at steady-state (AUCss)
4. Percentage of patients with antidrug antibodies (ADAs) to tislelizumab after subcutaneous (SC) or intravenous (IV) administration

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

BeOne Medicines AG

Sponsor organisation

BeOne Medicines AG

Address

Aeschengraben 27

City

Basel

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Public contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Third parties 8

Locations

6 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 66 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications