An Open-label, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dose Escalation: Number of participants with dose limiting toxicities (DLTs)
研究概览
简要总结
This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has the ability to understand and willingness to sign a written informed consent form.
- •Male or female from 18 years of age or older.
- •Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma.
- •Has at least one measurable lesion per RECIST v1.
- •Has a life expectancy of ≥ 12 weeks.
- •Adequate organ function.
排除标准
- •Patients with known active CNS metastases and/or cancerous meningitis.
- •Has received any type of systemic anticancer monoclonal antibodies or other immunosuppressants within 4 weeks prior to the first dose. Has received prior chemotherapy, targeted therapy, or other investigational therapy within 2 weeks prior to the first dose.
- •Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy.
- •Has impaired heart function,or clinically significant cerebrovascular and cardiovascular disease.
- •Subjects with dysphagia or known drug absorption disorders.
- •Has a history of any other malignancy within 5 years.
- •Has severe oncological complications.
- •Is currently participating in other clinical studies.
- •Subjects with be unsuitable for participation in the trial evaluated by investigator.
研究组 & 干预措施
Dose Escalation
Subjects will be assigned to pre-specified dose level to determine MTD/MAD of JMKX003948. Each treatment cycle will be 21 days.
干预措施: JMKX003948 (Drug)
Dose Expansion
Subjects will be assigned to the recommended dose level determined in dose escalation Phase. Each treatment cycle will be 21 days.
干预措施: JMKX003948 (Drug)
结局指标
主要结局
Dose Escalation: Number of participants with dose limiting toxicities (DLTs)
时间窗: Up to 2 months
Number of participants with DLTs
Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to 2 years
Number of participants with AEs/SAEs to characterize the safety and tolerability of JMKX003948.
Dose Expansion: Objective Response Rate (ORR)
时间窗: Up to 1 year
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
次要结局
- maximum plasma concentration (Cmax)(Up to 1 month)
- maximum plasma concentration (Tmax)(Up to 1 month)
- Duration of Response (DoR)(Up to 1 year)