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

Phase 2RecruitingNCT07099547

Suzhou Zelgen Biopharmaceuticals Co.,Ltd60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Biliary Tract Carcinoma

Interventions

ZG005DRUG

ZG005 20 mg/kg IV Q3W

TislelizumabDRUG

Tislelizumab 200mg IV Q3W

GemcitabineDRUG

Gemcitabine 1000mg/m\^2 Q3W. Gemcitabine will be administered on D1/D8 in every three weeks cycle.

Cisplatin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

RECRUITING

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time frame: Up to 2 years

Secondary Outcomes

Adverse Events (AEs)

Time frame: Up to 2 years

Central Contacts

Bo Liu

CONTACT

+86-0512-57309965 liub@zelgen.com

Data from ClinicalTrials.gov

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