NCT07099547

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

July 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 2, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

July 25, 2025

Last Update Submit

April 27, 2026

Conditions

Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    Up to 2 years

Secondary Outcomes (1)

  • Adverse Events (AEs)

    Up to 2 years

Study Arms (2)

Text group

EXPERIMENTAL

ZG005+Gemcitabine +Cisplatin

Drug: ZG005Drug: GemcitabineDrug: Cisplatin

Control group

EXPERIMENTAL

Tislelizumab+Gemcitabine+Cisplatin

Drug: TislelizumabDrug: GemcitabineDrug: Cisplatin

Interventions

ZG005DRUG

ZG005 20 mg/kg IV Q3W

Text group
TislelizumabDRUG

Tislelizumab 200mg IV Q3W

Control group
GemcitabineDRUG

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

Control groupText group
CisplatinDRUG

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

Control groupText group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Interventions

tislelizumabGemcitabineCisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Jason Wu

    Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    STUDY CHAIR

Central Study Contacts

Bo Liu

CONTACT

+86-0512-57309965liub@zelgen.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 1, 2025

Study Start

December 2, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

CN(1)