Malignant Solid Tumor
Conditions
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.
Interventions
DRUGFH-006 for Injection
FH-006 for injection.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Assessed up to 6 months. | ORR is the efficacy endpoint of FH-006 for injection monotherapy in treatment of patients with advanced solid tumors. |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum concentration (Tmax) | Up to 2 years. |
| Serious adverse events (SAEs) | Up to 24 weeks. |
| Terminal half-life (t1/2) | Up to 2 years. |
| Area Under the Concentration Versus Time Curve From Time Zero to T (AUC0-t) | Up to 2 years. |
| Adverse events (AEs) | Up to 24 weeks. |
| Maximum concentration (Cmax) | Up to 2 years. |
Countries
China
Contacts
CONTACTZhenqun Lu
Outcome results
None listed