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A Study of FZ-AD004 in Patients With Advanced Solid Tumors
Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Summary
This study is one single group of participants with advanced solid tumors. It is the first time the drug has been used in humans. There will be two parts including Dose Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FZ-AD004.
Official title: A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD004 in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
121
Start Date
2023-06-12
Completion Date
2027-12
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
FZ-AD004
Dose Escalation:Subjects will receive an intravenous infusion of FZ-AD004 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study. Dose Expansion:Subject will receive a single dose of FZ-AD004 at 1-2 dose level on Day1 of each cycles.
Locations (1)
Shanghai Chest Hospital
Shanghai, China