A Phase 1 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Combination With Toripalimab in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- DLTs
研究概览
简要总结
This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.
详细描述
This study is a study of Max-40279-01 in combination with toripalimab in patients with advanced solid tumors. This study includes two Parts, the Part 1 will assess the safety and efficacy of the preset several dose levels of Max-40279-01 and toripalimab, and recommend a dose level of Max-40279-01 combined toripalimab for stage 2. The part 2 is designed to study the efficacy and safety of max-40279-01 combined toripalimab in advanced solid tumors or certain specific tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Males and/or females over age 18
- •Histologically and/or cytologically documented local advanced or metastatic solid tumor.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival >3 months.
- •Signed informed consent form.
排除标准
- •Known uncontrolled or symptomatic central nervous system metastatic disease.
- •Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0) at the time of randomization.
- •Inadequate organ or bone marrow function.
- •Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- •Pregnant or breast-feeding woman.
- •Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments.
研究组 & 干预措施
dose level 1 of max-40279 combined dose level 1 of toripalimab
"MAX-40279-01" and "toripalimab"
干预措施: "MAX-40279-01" and "Toripalimab" (Drug)
dose level 2 of max-40279 combined dose level 1 of toripalimab
"MAX-40279-01" and "toripalimab"
干预措施: "MAX-40279-01" and "Toripalimab" (Drug)
dose level 2 of max-40279 combined dose level 2 of toripalimab
"MAX-40279-01" and "toripalimab"
干预措施: "MAX-40279-01" and "Toripalimab" (Drug)
dose level 3 of max-40279 combined dose level 2 of toripalimab
"MAX-40279-01" and "toripalimab"
干预措施: "MAX-40279-01" and "Toripalimab" (Drug)
recommend dose of max-40279 combined recommend dose level of toripalimab
"MAX-40279-01" and "toripalimab"
干预措施: "MAX-40279-01" and "Toripalimab" (Drug)
结局指标
主要结局
DLTs
时间窗: 21 days
Dose limiting toxicity
Incidence of Treatment-Emergent Adverse Events
时间窗: 24 months
Safety and tolerability assessed by incidence and severity of adverse events
次要结局
- Subsequent clinical recommended dose(12 months)
- Cmax(Approximately 6 months)
- Tmax(Approximately 6 months)
- AUC(Approximately 6 months)
- T1/2(Approximately 6 months)
- The blood concentration of toripalimab(Approximately 6 months)
- ADA(6 months)
- The efficacy end points: ORR、DCR，PFS，DOR，OS(24 months)
- the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors(24 months)