Status:
NOT_YET_RECRUITING
A Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Malignant Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy.
Eligibility Criteria
Inclusion
- Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study.
- Patients with unresectable recurrent or metastatic solid tumors.
- There is at least one lesion that could be measured.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Adequate organ functions as defined.
- Life expectancy ≥ 3 months.
Exclusion
- Patients with known active central nervous system (CNS) metastases.
- Subjects who had other malignancy in five years before the first dose.
- Patients with tumor-related pain that can not be controlled as determined.
- Patients with serious cardiovascular and cerebrovascular diseases.
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
- Patients with severe infections.
- History of immunodeficiency.
- History of autoimmune diseases.
- Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy.
- Active infection.
- Pregnant or nursing women.
- Known history of serious allergic reactions to the investigational product or its main ingredients.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07136142
Start Date
August 1 2025
End Date
February 1 2027
Last Update
August 22 2025
Active Locations (2)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
2
Tianjin Medical Unversity Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300181