NCT03894150已完成1 期
A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年4月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- MTD
研究概览
简要总结
This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematologic malignancies.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •With relapsed/refractory CD30+ disease that histologically confirmed by central laboratory assessment and pathology review (Priority for cHL, ALCL and MF).
- •Patients must have at least one site of measurable disease by conventional CT scan (defined by unidimensional lymph node lesion ≥ 15 mm or extranodal lesion ≥ 10 mm ), patients with MF, skin nodules can be measured by caliper to meet the criteria as measurable lesions, positive FDG uptake for cHL and ALCL.
- •Patients must have the following required baseline laboratory data: Hb≥80g/L, NEUT≥1.5×109/L, PLT≥75×109/L, TBIL≤1.5 times ULN, ALT/AST≤2.5 times ULN, Cr≤1.25 times ULN or Ccr≥45 ml/min, INR≤1.5 times ULN, APTT≤1.5 times ULN.
- •Patients must be at least 8 weeks apart from the previous autologous stem cell infusion therapy prior to the first dose.
- •Patients must be at least 4 weeks apart from previous radiotherapy, chemotherapy, biologics, immunotherapy, and/or other research-based anticancer therapy prior to the first dose (with nitrogen mustard, melphalan, and nitrosourea for at least 6 weeks).
- •Patients must have a life expectancy > 3 months.
- •Voluntary consent form
排除标准
- •Patients who have received an allogeneic stem cell transplant.
- •Patients who have had previous treatment with any anti-CD30 antibody.
- •Patients received antibody therapy 6 weeks or 5 plasma half-life before the first dose.
- •Patients who are receiving other anti-tumor treatments.
- •The toxicity of previous anti-tumor treatment has not recovered to grade 1 or below, except for grade 2 peripheral neurotoxicity and any level of alopecia.
- •Other primary malignant tumors have been seen in the past 3 years (except for cervical cancer in situ or non-melanoma skin cancer or prostate cancer with specific prostate specific antigen).
- •Participants with cardiovascular conditions specified in protocols.
- •NYHA classification grading of cardiac function III/IV.
- •Participants with brain or meningeal disease conditions specified in protocols.
- •Patients with poor diabetes control,
- •High-risk participants with a history of > grade 2 peripheral neuropathy or any active neurologic disease.
- •Patients have psychiatric history.
- •Patients with a history of liver fibrosis or cirrhosis and clinical signs and symptoms suggesting liver fibrosis or cirrhosis.
- •Patients with previous interstitial pneumonia.
- •Patients have active systemic viral, bacterial or fungal infection 4 weeks prior to the first dose
- •HIV antibody positive / HBsAg positive / HCVAb positive.
- •Patients who are allergic to recombinant proteins, murine proteins or to the drug excipients.
- •Patients who are receiving a dose ≥ 20 mg/day of prednisone or glucocorticoid therapy.
- •Female patients who are breastfeeding or pregnant.
- •Patients with fertility who refuses to use contraception during the trial period and within 6 months after the end of the last dose.
- •Other reasons that researchers believe are inappropriate to participate in this study.
研究组 & 干预措施
F0002-ADC
Experimental
干预措施: F0002-ADC (Drug)
结局指标
主要结局
MTD
时间窗: Within 21 days after a single dose
the maximum tolerable dose
次要结局
- Incidence of adverse events(Till 1 month after last dose)
- Incidence of laboratory abnormalities(Till 1 month after last dose)
- Maximum Plasma Concentration [Cmax](1 months after last dose)
- Tmax(1 months after last dose)
- ORR(Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years)
- PFS(Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years)
- Area Under the Curve [AUC](1 months after last dose)
- Half-life Time [T1/2](1 months after last dose)
- Clearance [CL](1 months after last dose)
- Apparent Volume of Distribution [Vd](1 months after last dose)
- Immunogenicity(1 months after last dose)
- DOR(Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years)
研究者
研究点 (2)
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