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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Recommended Phase II dose (RP2D)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Adequate organ functions as defined.
- •Life expectancy ≥ 3 months.
排除标准
- •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.
研究组 & 干预措施
FH-006 Group
Firstly, FH-006 for injection monotherapy should be conducted for some tumors. Then FH-006 in combination with other anti-cancer treatment would be conduction for the specific tumor, including SHR-1316 injection with or without Albumin-bound paclitaxel.
干预措施: FH-006 for Injection (Drug)
FH-006 Group
Firstly, FH-006 for injection monotherapy should be conducted for some tumors. Then FH-006 in combination with other anti-cancer treatment would be conduction for the specific tumor, including SHR-1316 injection with or without Albumin-bound paclitaxel.
干预措施: SHR-1316 Injection (Drug)
FH-006 Group
Firstly, FH-006 for injection monotherapy should be conducted for some tumors. Then FH-006 in combination with other anti-cancer treatment would be conduction for the specific tumor, including SHR-1316 injection with or without Albumin-bound paclitaxel.
干预措施: Paclitaxel for Injection (Albumin-Bound) (Drug)
结局指标
主要结局
Recommended Phase II dose (RP2D)
时间窗: From the first dose of study medication up to 28 days.
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs)
时间窗: From signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks.
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Objective Response Rate (ORR)
时间窗: Assessed up to 6 months.
ORR is the efficacy endpoint of FH-006 for injection monotherapy in treatment of patients with advanced solid tumors.
次要结局
- 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.)