NCT06239298

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	ZG005 Powder for Injection	intravenous infusion(IV), once every 3 weeks
DRUG	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

Timeline

• Start date: 2024-05-10
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2024-02-02
• Last updated: 2024-06-14

Locations

1 site across 1 country: China