Study of ZG005 in Patients With Advanced Solid Tumors

Phase 2

Not yet recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Biological: ZG005 for Injection

• Registration Number: NCT06927687
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Study Start: 2025-05
• Primary Completion: 2027-05
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Expansion	ZG005 for Injection	ZG005 dose expansion was performed in different tumors, such as: nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and other carcinoma

Primary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Adverse Event (AE)	Up to 2 years

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China