A Single-arm, Open-label, Multicenter,Phase I Study of Linperlisib Combination With Camrelizumab in Patients With Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 入组人数
- 118
- 主要终点
- DLTs
研究概览
简要总结
It is a single-arm, open-label, multicenter, phase I trial,aiming at exploring the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,observing the preliminary efficacy.
详细描述
The trial can be divided into two parts: dose escalation part and dose expansion part.
Camrelizumab will be administrated intravenously in a predetermined fixed dose(200mgQ3w）in both parts.
In dose escalation part,Linperlisib will be administrated from 40mgQD,60mgQD to 80 mgQD in sequence with the classic "3+3" design.The purposes of this part are figuring out the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,and observing the PK characteristics of Linperlisib when using combination with Camrelizumab.
When finishing the dose escalation part,one combination dose of Linperlisib with Carelizumab will be selected to be studied on a wider scale of patients with advantage solid tumor in dose expansion part.Purposes of this part are further observing the PK characteristics of Linperlisib when using combination with Camrelizumab,while observing the preliminary efficacy of Linperlisib when using combination with Camrelizumab.
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
- •18 years old≦age≦75 years old;
- •Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors；
- •Failure of previous standard treatment (sufficient prior treatment and no better treatment than participating in clinical research);
- •Qualified basic organ function and body condition;
- •The expected survival is greater than 3 months;
- •Adequate washout period.
排除标准
- •Prior allergy to study drug components;
- •Chronic metabolic diseases that are poorly controlled by medication;
- •Brain metastases, infection, hemorrhage, autoimmune disease or cardiovascular disease, whichever is in active state;
- •Digestive tract diseases that affect absorption of studied drugs.
研究组 & 干预措施
Linperlisib +Camrelizumab 200mgQ3w
Linperlisib will be administrated orally from 40mgQD, 60mgQD to 80mgQD in sequence during dose excalation part and a selected dose in dose expansion part,for 21 consecutive days as a treatment cycle; Camrelizumab will be administrated intravenously 200mg every 3 weeks in all patients just before the administration of Linperlisib.
干预措施: Linperlisib Tablet (Drug)
结局指标
主要结局
DLTs
时间窗: At the end of Cycle 1 (each cycle is 21 days)
dose limited toxicities
TEAEs
时间窗: from day 1after taking the investigational product till 30 days after withdrew from the study
treatment emergent adverse events
次要结局
- Drug exposure(At the end of Cycle 1 (each cycle is 21 days))
- PK parameters(At the end of Cycle 1 (each cycle is 21 days))
- Effectiveness evaluation index(From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)