Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma
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
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
60 participants
Dec 2, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Fully understand the study and voluntarily sign the informed consent form.
- Subjects with a histopathological or cytologically diagnosis of Gallbladder cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy of at least 3 months.
Exclusion Criteria1
- Participants were deemed unsuitable for participating in the study by the investigator for any reasons.
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Interventions
ZG005 20 mg/kg IV Q3W
Tislelizumab 200mg IV Q3W
Gemcitabine 1000mg/m\^2 Q3W. Gemcitabine will be administered on D1/D8 in every three weeks cycle.
Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07099547