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

NCT ID: NCT07099547

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Biliary Tract Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Text group

ZG005+Gemcitabine +Cisplatin

Group Type EXPERIMENTAL

ZG005

Intervention Type DRUG

ZG005 20 mg/kg IV Q3W

Gemcitabine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.

Control group

Tislelizumab+Gemcitabine+Cisplatin

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Tislelizumab 200mg IV Q3W

Gemcitabine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.

Interventions

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ZG005

ZG005 20 mg/kg IV Q3W

Intervention Type DRUG

Tislelizumab

Tislelizumab 200mg IV Q3W

Intervention Type DRUG

Gemcitabine

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

Intervention Type DRUG

Cisplatin

Cisplatin 25mg/m\^2 Q3W. Cisplatin will be administered on D1/D8 in every three weeks cycle.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

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

Hefei, Anhui, China

Site Status

Countries

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China

Central Contacts

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Bo Liu

Role: CONTACT

+86-0512-57309965

Facility Contacts

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Lianxin Liu

Role: primary

Other Identifiers

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ZG005-007

Identifier Type: -

Identifier Source: org_study_id

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