Study of ZG005 in Patients With Advanced Solid Tumors | NCT06927687

Studies
Study of ZG005 in Patients With Advanced Solid Tumors

NCT06927687

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Status

Active, not recruiting

Last Update Posted

Apr 29, 2026Actual

Enrollment

50Actual

Phase

Phase 2

Conditions

Advanced Solid Tumor

Interventions

ZG005 for Injection

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

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2025Actual

Primary Completion Date

May 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Apr 7, 2025

First Submission Date that Met QC Criteria

Apr 7, 2025

First Posted Date

Apr 15, 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

Apr 29, 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 an open-label, multicenter, Phase II clinical trial, designed to evaluate the efficacy and safety of ZG005 in patients with advanced solid tumors who have previously failed or are intolerant to standard treatment.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Expansion	Experimental	ZG005 dose expansion was performed in different tumors, such as: nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and other carcinoma	Biological: ZG005 for Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZG005 for Injection	Biological	Recommended Phase 2 Dose (RP2D) of ZG005(20 mg/kg), intravenous infusion, once every 3 weeks.	Dose Expansion

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

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

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;
Life expectancy ≥ 12 weeks;
Histologically or cytologically confirmed diagnosis of advanced solid tumors.

Exclusion Criteria:

Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
Any other malignancy within 5 years.

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

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University Cancer Center		Guangzhou	Guangdong		China

Intervention Browse Module

MeSH Terms

ID	Term
D007267	Injections

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

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Browse Branches

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