RecruitingPhase 2NCT06927687

Study of ZG005 in Patients With Advanced Solid Tumors

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


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

100 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria2

  • 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.

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Interventions

BIOLOGICALZG005 for Injection

Recommended Phase 2 Dose (RP2D) of ZG005(20 mg/kg), intravenous infusion, once every 3 weeks.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06927687


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