NCT03460457Unknown1 期
Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 主要终点
- maximum tolerated dose(MTD)
研究概览
简要总结
To study the pharmacokinetic characteristics of TQB2450 in the human body, recommend a reasonable regimen for subsequent research.
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
- •Patients with advanced malignancy diagnosed with pathology or cytology who have failed standard treatment or no standard treatment;
- •18-70 years old;Eastern Cooperative Oncology Group performance status:0-1,Life expectancy of more than 3 months;
- •Main organs function is normal;
- •Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped;
- •Patients should be voluntary and sign the informed consents before taking part in the study;
排除标准
- •Patients who have received programmed cell death protein 1(PD-1) or programmed cell death protein ligand(PD-L1) antibody treatment;
- •Patients who had any> 3 degree immune-related adverse event during any previous immunotherapy received;
- •Appeared severe hypersensitivity after taking other monoclonal antibody drugs;
- •Other malignancies have been diagnosed in the past 2 years except cured or locally curable cancers, such as cutaneous or squamous cell carcinoma, superficial bladder cancer, cervical cancer or orthotopic carcinoma of the breast;
- •Known spinal cord compression, cancer meningitis patients, new onset of central nervous system metastasis or stable control of symptoms in patients with brain metastases less than 4 weeks; asymptomatic and stable imaging without the need for corticosteroid treatment；
- •Patients with hypothyroidism over 2 degrees;
- •Patients with active, or who have had, and are likely to relapse, autoimmune diseases; the following patients are enrolled: skin disorders without systemic treatment (eg vitiligo, psoriasis, hair loss);
- •Patients treated with glucocorticoids or other immunosuppressive agents within 4 weeks prior to dosing;
- •Interstitial lung disease or non-contagious pneumonia (including past history and current illness); uncontrolled systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc. except for radiotherapy-induced interstitial pneumonitis;
- •Serious chronic or active infections require systemic antibacterial, antifungal or antiviral treatment (allowing antiviral treatment in patients with hepatocellular carcinoma), including tuberculosis infection;
- •Unstable pleural effusion, pericardial effusion or ascites;
- •Significant cardiovascular diseases such as heart failure of New York Heart Academy(NYHA) Class 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval ≥480 ms) or unstable Angina;
- •Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
- •Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication;
- •Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C;
- •The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives;
- •The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives;
- •Inoculated with vaccine or attenuated vaccine within 4 weeks before first administration;
- •Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose;
研究组 & 干预措施
TQB2450
Experimental
干预措施: TQB2450 (Drug)
结局指标
主要结局
maximum tolerated dose(MTD)
时间窗: 21 days
dose-limiting toxicity(DLT)
时间窗: 21 days
次要结局
- Peak Plasma Concentration(Cmax)(21 days)
- Peak time（Tmax）(21 days)
- Half life（t1/2）(21 days)
- Area under the plasma concentration versus time curve (AUC)(21 days)
- Clearance（CL）(21 days)
- objective response rate(ORR)(evaluated in the end of each 3 cycles up to intolerance the toxicity or progression disease (up to 24 months))
研究者
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