Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Conditions
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.
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.
Interventions
DRUGSubcutaneous Tislelizumab
Administered by subcutaneous injection
Administered by intravenous infusion
DRUGCisplatin
Administered by intravenous infusion
DRUGLeucovorin
Administered by intravenous infusion
DRUG5-fluorouracil (5-FU)
Administered by intravenous infusion
DRUGOxaliplatin
Administered by intravenous infusion
DRUGCapecitabine
Administered orally
Sponsors
BeOne Medicines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab | 85 Days |
| Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab | 21 Days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 2 years | 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 |
| Progression-Free Survival (PFS) | Up to 2 years | 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 |
| Duration of Response (DOR) | Up to 2 years | 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 |
| Disease Control Rate (DCR) | Up to 2 years | 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 |
| Overall Survival (OS) | Up to 2 years | OS is defined as the time from first study drug administration to the date of death due to any cause |
| Number of Participants With Adverse Events (AEs) | Up to 2 years | 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. |
| Model-predicted Serum Ctrough at Cycle 1 | 21 Days | — |
| Observed Serum Ctrough at Cycle 1 | 21 Days | — |
| Observed Area Under the Concentration-time Curve at Steady-state (AUC) at Cycle 1 | 21 Days | — |
| Model-predicted Area Under the Concentration-time Curve at Steady-state (AUCss) | 85 Days | — |
| Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab after SC or IV Administration | Up to 2 years | — |
Countries
Austria, Brazil, China, Czechia, France, Italy, Japan, Poland, Puerto Rico, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTBeOne Medicines
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed