A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor
NCT06239298 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2024-06-14
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
Interventions
- 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
Sponsors & Collaborators
-
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
lead INDUSTRY
Principal Investigators
-
Jason Wu · Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-10
- Primary Completion
- 2026-03-31
- Completion
- 2026-05-31
Countries
- China
Study Locations
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