Study of ZG005 Combined With Gecacitinib in Patients With... | NCT06903377

Studies
Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer

NCT06903377

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Status

Recruiting

Last Update Posted

Jan 5, 2026Actual

Enrollment

50Estimated

Phase

Phase 1Phase 2

Conditions

Non-small Cell Lung Cancer

Interventions

ZG005 for Injection
Gecacitinib Hydrochloride Tablets

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

Dec 2025

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

May 23, 2025Actual

Primary Completion Date

Apr 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Mar 24, 2025

First Submission Date that Met QC Criteria

Mar 24, 2025

First Posted Date

Mar 30, 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

Dec 30, 2025

Last Update Posted Date

Jan 5, 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 multicenter Phase I/II study for patients with advanced non-small cell lung cancer who have failed PD-1/L1 therapy, aiming to evaluate the safety of ZG005 in combination with Gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part1-Group A	Experimental	ZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid	Biological: ZG005 for Injection Drug: Gecacitinib Hydrochloride Tablets
Part1-Group B	Experimental	ZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid	Biological: ZG005 for Injection Drug: Gecacitinib Hydrochloride Tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZG005 for Injection	Biological	intravenous infusion	Part1-Group A Part1-Group B

Measure	Description	Time Frame
Adverse Event (AE)		Up to 2 years

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fully understand this study and voluntarily sign the ICF.
Age 18-75 years, no gender restriction.
Patients with locally advanced or recurrent/metastatic squamous and/or non-squamous non-small cell lung cancer confirmed by histology/cytology, unsuitable for radical therapy.

Exclusion Criteria:

Medical history, CT scan, or MRI indicates the presence of CNS metastases.
Other malignancies within 5 years.
Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

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
Cong Zhang	Contact	17602176888		zhangc@zelgen.com

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Chest Hospital	Recruiting	Shanghai	Shanghai Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007267	Injections

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided