Tislelizumab
DrugAdministered by intravenous infusion
Other names: BGB-A317
NCT Number: NCT07554521
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Los Angeles Cancer Network, Los Angeles, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered by intravenous infusion
Other names: BGB-A317
Administered orally
Administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Time frame: Approximately 12 months
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
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
Time frame: Approximately 12 months
Contact information is provided by the study sponsor or research team.
BeOne Medicines
Industry
An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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