Study of ZG005 in Patients With Advanced Solid Tumors

April 27, 2026 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

A Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of ZG005 in Patients With Advanced Solid Tumors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Expansion
ZG005 dose expansion was performed in different tumors, such as: nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and other carcinoma
Biological: ZG005 for Injection
Recommended Phase 2 Dose (RP2D) of ZG005(20 mg/kg), intravenous infusion, once every 3 weeks.
Other Names:
  • ZG005

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

  • Study Chair: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZG005-001-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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