RecruitingPhase 1Phase 2NCT06938880

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

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


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

60 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

Interventions

BIOLOGICALZGGS18 for Injection

Intravenous infusion

BIOLOGICALZG005 for Injection

Intravenous infusion


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06938880


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