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Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Summary
Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.
Official title: A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-12-23
Completion Date
2027-12
Last Updated
2025-12-05
Healthy Volunteers
No
Conditions
Interventions
FH-006
Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days
FH-006
administered once every 3 weeks (Q3W), with a treatment period of 21 days
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China