NCT07836036尚未招募1 期
A Phase I, Multi-center, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ASKC189 in Chinese Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors Carrying RAS Gene Mutations.
适应症
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
- 200
- 试验地点
- 2
- 主要终点
- The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
研究概览
简要总结
This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ASKC189 in in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
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
- •Aged ≥18 years old at the time of informed consent
- •Able to provide informed consent voluntarily before any study-related activities and according to local guidelines
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Have an estimated life expectancy ≥ 12 weeks
- •Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.
- •Documentation of KRAS/NRAS/HRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory
- •Have consented to provide archival tumor tissue collected within 3 years or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
- •Have adequate organ functions
- •Have discontinued all previous treatments for cancer with resolution of any adverse events (AEs) to ≤ Grade 1
排除标准
- •Are currently enrolled in a clinical study involving an investigational product or any other type of medical research
- •Have tumors previously tested positive for Class I BRAF mutations i.e. V600X
- •Prior treatment with a pan-RAS(ON) inhibitor
- •Gastrointestinal conditions that may interfere with drug absorption
- •Have a serious concomitant systemic disorder
- •Have a serious pre-existing medical condition(s)
- •Prior or second concurrent primary malignancies
- •Moderate or severe cardiovascular disease
- •Have symptomatic central nervous system (CNS) malignancy or metastasis
研究组 & 干预措施
ASKC189 oral capsule
Experimental
干预措施: ASKC189 (Drug)
结局指标
主要结局
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
时间窗: Up to 21 days following first dose
DLT is short for Dose Limiting Toxicity, dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Number of participants with adverse events and serious adverse events as assessed by CTCAE v6.0
时间窗: Up to 30 days following last dose
AE refers to any untoward medical occurrence or deterioration of existing medical event after the investigational treatment, whether or not considered related to the study treatment.
次要结局
- Characterization of the PK profile of ASKC189(At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose)
- Characterization of the PK profile of ASKC189: blood concentration characteristics(At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose)
- Characterization of the PK profile of ASKC189: steady state characterization(At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose)
- Characterization of the PK profile of ASKC189: drug level characterization in blood(At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose)
- Objective response rate (ORR)(Up to approximately 3 years)
- Disease control rate (DCR)(Up to approximately 3 years)
- Duration of Response (DoR)(Up to approximately 3 years)
- Progression-free survival (PFS)(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 3 years)
研究者
研究点 (2)
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