NCT04387916招募中1 期
A Phase I, Open-label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of KC1036 in the Patients with Advanced Recurrent or Metastatic Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 207
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed recurrent or metastatic solid tumors;
- •Patients who have failed standard or conventional treatment, Including chemotherapy, targeted therapy, immunotherapy:
- •Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy;
- •At least one measurable lesion (by RECIST 1.1);
- •Eastern Cooperative Oncology Group performance status score of 0 or 1;
- •Life expectancy > 12 weeks;
- •Patients should participate in the study voluntarily and sign informed consent.
排除标准
- •Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
- •Other kinds of malignancies;
- •Hematologic, renal, and hepatic function abnormities;
- •Risk of bleeding;
- •Gastrointestinal abnormalitiest;
- •Cardiovascular and cerebrovascular diseases;
- •Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks of enrollment;
- •Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia;
- •Involved in other clinical trials within 4 weeks of enrollment;
- •Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks days of enrollment;
- •History of organ allograft;
- •Need immunosuppressive agents or systemic or absorbable topical hormone therapy for immunosuppression;
- •Uncontrolled ongoing or active infection;
- •Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
- •Pregnant or lactating women or those who do not take contraceptives, including men;
- •Suffering from mental and neurological diseases;
- •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
KC1036
Experimental
Patients take a single dose of KC1036 for the pharmacokinetic study, then off for 5 days before the first cycle begins. In the subsequent treatment cycles, KC1036 are given orally once daily, 21 days as a cycle.
干预措施: KC1036 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: First 4 weeks after initial administration of KC1036
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Adverse events (AEs)
时间窗: From enrollment up to 30 days after last dose
Incidence of treatment-related AEs
次要结局
- Pharmacokinetics (PK) profile: Tmax(First 4 weeks after initial administration of KC1036)
- Objective Response Rate (ORR)(Every 6 weeks for the duration of study participation; estimated to be 12 months)
- Duration of Response (DOR)(Every 6 weeks for the duration of study participation; estimated to be 12 months)
- Pharmacokinetics (PK) profile: Cmax(First 4 weeks after initial administration of KC1036)
- Disease Control Rate (DCR)(Every 6 weeks for the duration of study participation; estimated to be 12 months)
- Overall Survival (OS)(From the first medication to death due to any cause; estimated to be the subject's death, loss to follow-up, or end of the study])
- Pharmacokinetics (PK) profile: T1/2(First 4 weeks after initial administration of KC1036)
- Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞(First 4 weeks after initial administration of KC1036)
- Progression-free survival (PFS)(Every 6 weeks for the duration of study participation; estimated to be 12 months)
研究者
研究点 (3)
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