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NCT Number: NCT07099547

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

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.

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Key information

Conditions

Biliary Tract Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Hefei, Anhui, 230001, China

Location status: Recruiting

Location contact

Lianxin Liu

CONTACT

Lianxin Liu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZG005

Drug

ZG005 20 mg/kg IV Q3W

Tislelizumab

Drug

Tislelizumab 200mg IV Q3W

Gemcitabine

Drug

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

Cisplatin

Drug

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

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 2 years

Secondary outcomes

  1. Adverse Events (AEs)

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Liu

CONTACT

[email protected]

+86-0512-57309965

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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