A Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
Not Applicable
Not yet recruiting
- Conditions
- Malignant Solid Tumor
- Interventions
- Drug: FH-006 for Injection
- Registration Number
- NCT07136142
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FH-006 Group FH-006 for Injection FH-006 for injection monotherapy should be conducted.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time to maximum concentration (Tmax) Up to 2 years. Maximum concentration (Cmax) Up to 2 years. 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. Serious adverse events (SAEs) Up to 24 weeks.
Trial Locations
- Locations (2)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Tianjin Medical Unversity Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
Fudan University Shanghai Cancer Center🇨🇳Shanghai, Shanghai, China