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

Zelgen Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Biliary Tract Carcinoma

Treatments: Drug: ZG005; Drug: Cisplatin; Drug: Tislelizumab; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07099547

ZG005-007

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Text group

Experimental group

Description:

ZG005+Gemcitabine +Cisplatin

Treatment:

Drug: Gemcitabine

Drug: Cisplatin

Drug: ZG005

Control group

Experimental group

Description:

Tislelizumab+Gemcitabine+Cisplatin

Treatment:

Drug: Gemcitabine

Drug: Tislelizumab

Drug: Cisplatin