NCT07118709尚未招募1 期
A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Preliminary Efficacy of KC1086 in the Patients With Advanced Recurrent or Metastatic Solid Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1086 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into two parts: dose-escalation phase and dose-expansion 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 or for whom no standard treatment is available( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);
- •Participants with advanced recurrent, unresectable, and/or metastatic tumors must have evaluable or measurable lesions (according to RECIST 1.1)；
- •Eastern Cooperative Oncology Group performance status score of 0 or 1;
- •Life expectancy > 12 weeks;
- •Adequate bone marrow, 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 untreated central nervous system (CNS) metastasis;
- •Other kinds of malignancies within 5 years;
- •Gastrointestinal abnormalities;
- •Cardiovascular and cerebrovascular diseases;
- •Involved in other clinical trials within 4 weeks before enrollment;
- •Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;
- •Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;
- •Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
- •Severe infection within 4 weeks prior to enrollment;
- •Uncontrolled massive ascites, pleural or pericardial effusion；
- •Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
- •Prior therapies with KAT6 inhibitors
- •Pregnant or lactating women;
- •Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.
- •Other patients are not eligible for enrollment assessed by investigators.
研究组 & 干预措施
KC1086
Experimental
KC1086 are given orally once daily, 21 days as a cycle
干预措施: KC1086 (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: approximately 3 years
Incidence of treatment-related AEs
次要结局
- Pharmacokinetics (PK) profile: Cmax(approximately 3 years)
- Pharmacokinetics (PK) profile: Tmax(approximately 3 years)
- Pharmacokinetics (PK) profile: T1/2(approximately 3 years)
- Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞(approximately 3 years)
- Objective Response Rate (ORR)(approximately 3 years)
- Progression-free survival (PFS)(approximately 3 years)
- Disease Control Rate (DCR)(approximately 3 years)
- Duration of Response (DOR)(approximately 3 years)
研究者
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