A Study of ZG005 in Patients With Advanced Solid Tumors

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Biological: ZG005 Powder for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06233292

ZG005-001

Details and patient eligibility

About

This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose.

Enrollment: 484 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fully understand the study and voluntarily sign the informed consent form.
• Male or female 18-70 years of age;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
• Life expectancy ≥ 3 months;
• 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: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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484 participants in 2 patient groups

Part 1: Dose Escalation

Experimental group

Description:

The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).

Treatment:

Biological: ZG005 Powder for Injection

Biological: ZG005 Powder for Injection

Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy

Experimental group

Description:

The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma

Treatment:

Biological: ZG005 Powder for Injection

Biological: ZG005 Powder for Injection