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

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

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.

Inclusion Criteria:

1. Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study.
2. Patients with unresectable recurrent or metastatic solid tumors.
3. There is at least one lesion that could be measured.
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
5. Adequate organ functions as defined.
6. Life expectancy ≥ 3 months.

Exclusion Criteria:

1. Patients with known active central nervous system (CNS) metastases.
2. Subjects who had other malignancy in five years before the first dose.
3. Patients with tumor-related pain that can not be controlled as determined.
4. Patients with serious cardiovascular and cerebrovascular diseases.
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
6. Patients with severe infections.
7. History of immunodeficiency.
8. History of autoimmune diseases.
9. Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy.
10. Active infection.
11. Pregnant or nursing women.
12. Known history of serious allergic reactions to the investigational product or its main ingredients.