Study of ZG005 in Combination With Platinum-Based Chemoth... | NCT07099547

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

NCT07099547

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Status

Recruiting

Last Update Posted

May 1, 2026Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Biliary Tract Carcinoma

Interventions

ZG005
Tislelizumab
Gemcitabine
Cisplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2025Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jul 25, 2025

First Submission Date that Met QC Criteria

Jul 25, 2025

First Posted Date

Aug 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

May 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Text group	Experimental	ZG005+Gemcitabine +Cisplatin	Drug: ZG005 Drug: Gemcitabine Drug: Cisplatin
Control group	Experimental	Tislelizumab+Gemcitabine+Cisplatin	Drug: Tislelizumab Drug: Gemcitabine Drug: Cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZG005	Drug	ZG005 20 mg/kg IV Q3W	Text group
Tislelizumab

Measure	Description	Time Frame
Objective response rate (ORR)		Up to 2 years

Measure	Description	Time Frame
Adverse Events (AEs)		Up to 2 years

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bo Liu	Contact	+86-0512-57309965		liub@zelgen.com

Overall Officials

Name	Affiliation	Role
Jason Wu	Suzhou Zelgen Biopharmaceuticals Co.,Ltd	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of University of Science and Technology of China	Recruiting	Hefei	Anhui	230001	China

Intervention Browse Module

MeSH Terms

ID	Term
C000707970	tislelizumab
D000093542	Gemcitabine
D002945	Cisplatin

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided