Study of ZG005 in Combination With Gecacitinib and Chemot... | NCT07142837

Studies
Study of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors

NCT07142837

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Status

Not yet recruiting

Last Update Posted

Aug 27, 2025Actual

Enrollment

153Estimated

Phase

Phase 1Phase 2

Conditions

Advanced Solid Tumor

Interventions

ZG005
Gecacitinib

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

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2025Estimated

Primary Completion Date

Oct 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Aug 19, 2025

First Submission Date that Met QC Criteria

Aug 25, 2025

First Posted Date

Aug 27, 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

Aug 25, 2025

Last Update Posted Date

Aug 27, 2025Actual

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, open-label phase I/II study for participants with advanced solid tumors who have failed prior immune checkpoint inhibitor therapies.

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

153Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1: Dose Escalation	Experimental	Dose-escalation study of ZG005 in combination with Gecacitinib and Chemotherapy.	Drug: ZG005 Drug: Gecacitinib
Part 2: Dose Expansion	Experimental	Cohort A: HER2-negative gastric or gastroesophageal junction adenocarcinoma; Cohort B: Esophageal squamous cell carcinoma; Cohort C: other Solid Tumors.	Drug: ZG005 Drug: Gecacitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZG005	Drug	ZG005 20mg/kg; once every 3 weeks；IV infusion	Part 1: Dose Escalation Part 2: Dose Expansion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose Limiting Toxicity (DLT)		During the first 28 days
Objective Response Rate (ORR)		Up to 2 years
Adverse events (AEs)		Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fully understand the study and voluntarily sign the informed consent form.
Male or female 18-75 years of age.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
PART 1: Histologically confirmed unresectable locally advanced, recurrent, or metastatic solid tumors.PART 2 Cohort A: Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Cohort B: Histologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Cohort C: Histologically confirmed unresectable locally advanced, recurrent, or metastatic other solid tumors.
Life expectancy ≥ 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	051257309965		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
Chinese PLA General Hosptial		Beijing	Beijing Municipality		China