A Phase 1/2a Study of K-1728 in Advanced Solid Tumors (PIKYMA-01)
A First-in-Human Study of K-1728 Administered Alone and in Combination in Participants With Advanced or Metastatic Solid Tumors
This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors. The study assesses the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of K-1728.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- Adults with advanced or metastatic solid tumors who are able to provide consent
- Documented activating PIK3CA mutation
- ECOG performance status 0 or 1
- Adequate organ function
Key Exclusion Criteria:
- Active or untreated central nervous system disease
- Clinical significant or uncontrolled cardiovascular disease
- Significant or uncontrolled intercurrent illness
- Pregnant or breastfeeding
- Other protocol-defined exclusion criteria
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：K-1728 Monotherapy
Participants receive K-1728 orally as monotherapy |
K-1728 will be administered orally once daily in 28-day cycles |
|
实验性的：K-1728 + Endocrine Therapy
Participants receive K-1728 orally in combination with endocrine therapy |
K-1728 will be administered orally once daily in 28-day cycles Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle |
|
实验性的：K-1728 + Endocrine Therapy + CDK4/6 Inhibitor
Participants receive K-1728 orally in combination with endocrine therapy and a CDK4/6 inhibitor |
K-1728 will be administered orally once daily in 28-day cycles Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle Palbociclib will be administered orally on Days 1-21 in 28-day cycles |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum Tolerated Dose (MTD)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D)
大体时间：Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)
|
Determination of the MTD/MED and RP2D of K-1728 administered as monotherapy and in combination |
Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)
|
|
Incidence of Dose-Limiting Toxicities (DLTs)
大体时间：Initiation of study drug through Cycle 1 (28 days)
|
Number and percentage of participants experiencing a dose-limiting toxicity during the DLT-evaluation period with of K-1728 administered as monotherapy and in combination |
Initiation of study drug through Cycle 1 (28 days)
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
Number and percentage of participants with adverse events and serious adverse events with K-1728 administered as a monotherapy and in combination |
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
|
Changes in laboratory parameters
大体时间：From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
Compared to baseline, changes in laboratory parameters with K-1728 administered as monotherapy and in combination |
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
|
Changes in vital signs
大体时间：From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
Compared to baseline, changes in vital signs with K-1728 administered as monotherapy and in combination |
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
|
Changes in electrocardiogram (ECG) parameters
大体时间：From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
Compared to baseline, changes in ECG parameters (including QT interval, QTc interval, QRS complex, and PR interval) |
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
|
Changes in physical examination
大体时间：From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
Compared to baseline, changes in physical examination |
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728
大体时间：Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
|
Cmax of K-1728 when administered as monotherapy or in combination |
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
|
|
Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) of K-1728
大体时间：Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
|
Tmax of K-1728 when administered as monotherapy or in combination |
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
|
|
Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC) of K-1728
大体时间：Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
|
AUC of K-1728 when administered as monotherapy or in combination |
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
|
|
Pharmacokinetics - Half-life (t1/2) of K-1728 when administered as monotherapy or in combination
大体时间：Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
|
t1/2 of K-1728 when administered as monotherapy or in combination |
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
|
|
Preliminary Efficacy - Overall Response Rate (ORR)
大体时间：Initiation of study drug until disease progression, assessed up to approximately 24 months
|
Objective Response Rate (ORR) as assessed by RECIST v1.1 |
Initiation of study drug until disease progression, assessed up to approximately 24 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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