Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma

Not Applicable

Not yet recruiting

• Conditions: Biliary Tract Carcinoma
• Interventions: Drug: ZG005; Drug: Tislelizumab; Drug: Gemcitabine; Drug: Cisplatin

• Registration Number: NCT07099547
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-25
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-25
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01
• Study Start: 2025-09-01
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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 Criteria

• Participants were deemed unsuitable for participating in the study by the investigator for any reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text group	ZG005	ZG005+Gemcitabine +Cisplatin
Text group	Gemcitabine	ZG005+Gemcitabine +Cisplatin
Text group	Cisplatin	ZG005+Gemcitabine +Cisplatin
Control group	Tislelizumab	Tislelizumab+Gemcitabine+Cisplatin
Control group	Gemcitabine	Tislelizumab+Gemcitabine+Cisplatin
Control group	Cisplatin	Tislelizumab+Gemcitabine+Cisplatin

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	Up to 2 years

Trial Locations

Locations (1)

The First Affiliated Hospital of University of Science and Technology of China; 🇨🇳 Hefei, Anhui, China