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

ConditionBiliary Tract Carcinoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants were deemed unsuitable for participating in the study by the investigator for any reasons.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Text groupExperimental treatment 3 interventions

Group B: Control groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Objective response rate (ORR)

Time frame

Up to 2 years

Secondary outcomes

Adverse Events (AEs)

Time frame

Up to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov

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