A Study of ZG005 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Solid Tumors

• Registration Number: NCT06233292
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-17
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 484

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Adverse Event (AE)	Up to 24 Months	Number of participants with adverse events that are related to treatment
Dose Limiting Toxicities (DLT)	Up to 21Days	A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause.
Objective Response Rate	Up to 24 Months	Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Maximum tolerated dose (MTD)	Up to 24 Months	During the dose escalation stage, if 2 of up to 6 subjects in the first dose groups experienced DLT, then the dose level will be considered to be an intolerable dose or DLT dose level, and the previous lower dose will be considered to be the MTD.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China