A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Digestive System Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 133
- 试验地点
- 13
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.
详细描述
This is an open label, non-randomized，phase 1b/2 study to explore the preliminary antitumor activity of KC1036 in patients with advanced recurrent or metastatic digestive system tumors under BID or QD regimen.
The study will consist of two parts:
Part 1: QD regimen
To evaluate the efficacy and safety of KC1036 in the treatment of advanced recurrent, unresectable and / or metastatic digestive system tumors under 60mg QD regimen.
Part 2: BID regimen
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
- •Histologically or cytologically confirmed malignant digestive system tumors;
- •Patients with advanced recurrent, unresectable and / or metastatic digestive system tumors who have failed standard or conventional treatment:( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);
- •Eastern Cooperative Oncology Group performance status score of 0 or 1;
- •Life expectancy > 12 weeks;
- •BMI≥18.0;
- •Has adequate Hematologic, renal, and hepatic function;
- •Patients should participate in the study voluntarily and sign informed consent.
排除标准
- •Any patient who is known to have central nervous system (CNS) metastasis with clinical symptoms;
- •Other kinds of malignancies;
- •Gastrointestinal abnormalitiest;
- •Cardiovascular and cerebrovascular diseases;
- •Previous treatment with small molecule vascular targeting inhibitor；
- •Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks before enrollment;
- •Involved in other clinical trials within 4 weeks before enrollment;
- •Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks before enrollment;
- •Uncontrolled massive ascites,pleural/pericardial effusion;
- •Uncontrolled ongoing or active bacterial, viral or fungal infectious; Fever of unknown cause (> 38.5 ℃) occurred within 2 weeks before enrollment;
- •Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection ;
- •Pregnant or lactating women or those who do not take contraceptives, including men;
- •Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
- •Inability to comply with protocol required procedures.
研究组 & 干预措施
QD regimen
KC1036 was administered orally in 60 mg once daily, 21 days as a cycle.
干预措施: KC1036 (Drug)
BID regimen
Dose-Escalation part : KC1036 was administered orally in 20 mg BID, 30 mg BID, or 40 mg BID.
Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion .
干预措施: KC1036 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: approximately 2 year.
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.
次要结局
- Pharmacokinetics (PK) profile: Cmax(approximately 2 year.)
- Duration of Response (DOR)(approximately 2 year.)
- Disease Control Rate (DCR)(approximately 2 year.)
- Pharmacokinetics (PK) profile: AUC(approximately of 2 year.)
- Adverse events (AEs)(approximately of 2 year.)
- Pharmacokinetics (PK) profile: Tmax(approximately 2 year.)
- Pharmacokinetics (PK) profile: T1/2(approximately of 2 year.)
- Progression-free survival (PFS)(approximately 2 year)