Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors

December 30, 2025 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors, Including Cervical Cancer, Hepatocellular Carcinoma, Neuroendocrine Tumors, and Lung Cancer

This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Li Zhang

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 this study and voluntarily sign the ICF.
  • Age 18-75 years, no gender restriction.
  • Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology.

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.

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 Dose Escalation
ZG005 will be given 10mg/kg or 20mg/kg or other dose every three weeks and ZGGS18 will be given 10 mg/kg every three weeks
Biological: ZGGS18 for Injection
Intravenous infusion
Other Names:
  • ZGGS18
Biological: ZG005 for Injection
Intravenous infusion
Other Names:
  • ZG005
Experimental: Phase 2 Dose Expansion
ZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks
Biological: ZGGS18 for Injection
Intravenous infusion
Other Names:
  • ZGGS18
Biological: ZG005 for Injection
Intravenous infusion
Other Names:
  • ZG005

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limited toxicity(DLT)
Time Frame: up to 21 days
Incidence and severity of DLT events
up to 21 days
Adverse Event (AE)
Time Frame: Up to 2 years
Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
Up to 2 years
Maximum tolerated dose(MTD)
Time Frame: Up to 1 years
Up to 1 years
Recommended phase II dose(RP2D)
Time Frame: Up to 1 years
Up to 1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: Up to 2 years
Incidence of antidrug antibodies (ADA)
Up to 2 years
Objective response rate (ORR)
Time Frame: Up to 2 years
Objective Response Rate as Assessed by Investigator according to RECIST v1.1
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)

May 20, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZGGS18-ZG005-001

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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