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

Inclusion criteria

• 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 criteria

• 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.