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

NCT07099547 · tracked via the Priya Life Science China tracker

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase

Phase 2

Started

2025-12-02

Last updated

2026-05-01

Condition(s) studied

Biliary Tract Carcinoma

Investigational drug(s) / intervention(s)

ZG005TislelizumabGemcitabineCisplatin

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Objective response rate (ORR) — Up to 2 years

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui	Recruiting

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Other trials for the same condition

GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma Recruiting

A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies Recruiting

Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma Starting soon

Irinotecan Liposomes +5-FU/LV Versus Capecitabine in Patients of Recurrence After Resection of Resectable BTC Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07099547 on ClinicalTrials.gov ↗ ← All trials in China