A Study of ZG005 in Patients With Advanced Solid Tumors

Solid Tumors Clinical Trial

Official title:

A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233292
• Other study ID #: ZG005-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 17, 2022
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Yongsheng Chu
• Phone: +86-0512-57309965
• Email: chuys[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 484
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Biological:
• ZG005 Powder for Injection
The dose groups of ZG005 for dose escalations are set as 0.3 mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, and 20mg/kg, intravenous infusion, once every 3 weeks.
• ZG005 Powder for Injection
Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3 weeks.

Locations

Country	Name	City	State
China	Jilin Provincial Cancer Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities (DLT)	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.	Up to 21Days
Primary	Adverse Event (AE)	Number of participants with adverse events that are related to treatment	Up to 24 Months
Primary	Objective Response Rate	Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	Up to 24 Months
Primary	Maximum tolerated dose (MTD)	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.	Up to 24 Months