A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor

Solid Tumor Clinical Trial

Official title:

A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239298
• Other study ID #: ZG005-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 10, 2024
• Est. completion date: May 2026

Study information

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

Clinical Trial Summary

This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 2026
• Est. primary completion date: March 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 or

• Life expectancy = 3 months.

Exclusion Criteria:

• Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• ZG005 Powder for Injection
intravenous infusion(IV), once every 3 weeks
• Donafenib Tosilate Tablets
The dose groups of Donafenib for dose-exploration stage are set as 0.2g BID, 0.1g BID, and 0.1g QD, oral administration.The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Army Medical University	Chongqing	Chongqing

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	Objective Response Rate (ORR)	The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.	Up to 2 years
Primary	Dose Limiting Toxicity (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 2 years
Secondary	Duration of response (DOR)	Time from the first evaluated CR or PR until PD or death from any cause	Up to 2 years