NCT07099547

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Carcinoma

Interventions

Type	Name	Description
DRUG	ZG005	ZG005 20 mg/kg IV Q3W
DRUG	Tislelizumab	Tislelizumab 200mg IV Q3W
DRUG	Gemcitabine	Gemcitabine 1000mg/m\^2 Q3W. Gemcitabine will be administered on D1/D8 in every three weeks cycle.
DRUG	Cisplatin	Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-08-01
• Last updated: 2025-08-01

Locations

1 site across 1 country: China