NCT04623892Unknown1 期
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
TQB2618 is a TIM-3 receptor monoclonal antibody that binds to the extracellular domain of TIM-3 outside the cell to block the binding of TIM-3 to its ligand, thereby inhibiting the downstream signal transduction of TIM-3 and deactivating TIM-3 Inhibition of immune cells. The purpose of this study was to evaluate the safety, tolerability, pharmacokinetic parameters and antitumor effects of TQB2618 injection in subjects with advanced solid tumors.
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
- •Diagnosed as advanced malignant solid tumors and have failed standard treatments or lack effective treatments;
- •18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks;
- •Has at least one measurable lesion;
- •The function of main organs is normal;
- •Female patients of childbearing age must be negative in serum or urine HCG within 7 days before enrollment in the study, and must be non-lactating; patients should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
- •Understood and signed an informed consent form.
排除标准
- •Has Autoimmune disease;
- •Has received allogeneic bone marrow transplantation or solid organ transplantation;
- •Has brain disease or brain metastases;
- •Has cavity effusion;
- •Has cardiovascular diseases;
- •Has immunodeficiency diseases;
- •Has liver disease;
- •Has infection;
- •Has diabetes;
- •Has a history of psychotropic drug abuse or have a mental disorder;
- •Have a history of severe allergy to macromolecular drugs or allergy to known components of TQB2618 injection;
- •Has other malignant tumors within 2 years before the first medication;
- •Has received other anti-cancer drugs or anti-cancer treatments, or major surgical operations within 4 weeks before the first medication;
- •Has received any live vaccines or vaccines to prevent infectious diseases within 4 weeks before the first medication;
- •Has received local radiotherapy within 1 week before the first medication;
- •Toxicity (excluding hair loss) caused by previous anti-tumor therapy that has not recovered to CTC AE V5.0 level 1 or below;
- •Has major wound, severe ulcer or fracture that has not healed before 1 day before the first medication;
- •Has used systemic hormones, immune agonists, inhibitors, and regulators before 1 day before the first medication;
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
TQB2618
Experimental
TQB2618 administered intravenously (IV) on Day 1 of each 21-day.
干预措施: TQB2618 injection (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Baseline up to 28 days
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
次要结局
- Duration of response (DOR)(Up to 48 weeks)
- t1/2(Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.)
- AUC0-t(Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.)
- Overall response rate (ORR)(Up to 48 weeks)
- Progression-free survival (PFS)(Up to 48 weeks)
- Disease control rate（DCR）(Up to 48 weeks)
- Tmax(Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.)
- Cmax(Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.)
- Receptor occupation (RO)(Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days.)
研究者
研究点 (1)
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