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Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Summary
This is a randomized, open-label, phase II study evaluating first-line treatment for advanced gallbladder cancer. It aims to assess the efficacy, safety, pharmacokinetics, and immunogenicity of the ZG005 in Combination with gemcitabine and cisplatin as first-line therapy in Participants with advanced gallbladder cancer.
Official title: A Study to Evaluate the Efficacy and Safety of ZG005 in Combination With Platinum-Based Chemotherapy as First-Line Treatment in Participants With Advanced Biliary Tract Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-09
Completion Date
2027-12
Last Updated
2025-08-01
Healthy Volunteers
No
Conditions
Interventions
ZG005
ZG005 20 mg/kg IV Q3W
Tislelizumab
Tislelizumab 200mg IV Q3W
Gemcitabine
Gemcitabine 1000mg/m\^2 Q3W. Gemcitabine will be administered on D1/D8 in every three weeks cycle.
Cisplatin
Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.
Locations (1)
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China