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RECRUITING
NCT06735144
PHASE1/PHASE2

Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

FH-006

Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days

DRUG

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