The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or metastatic gastric or gastroesophageal cancer (GAC/GEA) or esophageal squamous cell carcinoma (ESCC). The study duration will be up to approximately 6 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered by intravenous infusion
Administered orally
Administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Helios Clinical Research
Cerritos, California, United States
RECRUITINGLos Angeles Cancer Network
Los Angeles, California, United States
RECRUITINGBrcr Coral Springs
Coral Springs, Florida, United States
RECRUITINGBioresearch Partners Holding Hialeah Hospital
Hialeah, Florida, United States
RECRUITINGFlorida Clinical Trials Group Plantation
Plantation, Florida, United States
RECRUITINGFlorida Clinical Trials Group Tamarac
Tamarac, Florida, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGGabrail Cancer Center Research
Canton, Ohio, United States
RECRUITINGNumber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 \[NCI-CTCAEv5.0\]\[1\]), timing, seriousness, and relationship to study treatment in GAC/GEA and ESCC participants, respectively
Time frame: Approximately 12 months
Overall Response Rate (ORR) as Assessed by the Investigator
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
Time frame: Approximately 12 months
Serum Concentrations of Tislelizumab
Time frame: Approximately 12 months
Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab
Time frame: Approximately 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.