Study of ZG005 in Patients With Advanced Solid Tumors

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Advanced Solid Tumor

Treatments: Biological: ZG005 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06927687

ZG005-001-02

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Dose Expansion

Experimental group

Description:

ZG005 dose expansion was performed in different tumors, such as: nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and other carcinoma

Treatment:

Biological: ZG005 for Injection