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NCT Number: NCT06938880

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

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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Li Zhang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZGGS18 for Injection

Biological

Intravenous infusion

Other names: ZGGS18

ZG005 for Injection

Biological

Intravenous infusion

Other names: ZG005

Primary outcomes

  1. Dose limited toxicity(DLT)

    Time frame: up to 21 days

    Incidence and severity of DLT events

  2. Adverse Event (AE)

    Time frame: Up to 2 years

    Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.

  3. Maximum tolerated dose(MTD)

    Time frame: Up to 1 years

  4. Recommended phase II dose(RP2D)

    Time frame: Up to 1 years

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 2 years

    Objective Response Rate as Assessed by Investigator according to RECIST v1.1

  2. Immunogenicity

    Time frame: Up to 2 years

    Incidence of antidrug antibodies (ADA)

Study contacts

Contact information is provided by the study sponsor or research team.

Siqi Jia

CONTACT

[email protected]

+86-0512-57018310

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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