An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-372 as a Single Agent and in Combination With Other Anti-Tumor Agents, in Patients With Advanced KRAS Mutant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 13
- 主要终点
- Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372
研究概览
简要总结
The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumor activity of TLN-372 as a single agent and in combination with other anti-tumor agents, in patients with advanced KRAS mutant solid tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Patients must have measurable disease at study entry.
- •Patients must have locally advanced or metastatic KRAS mutant solid tumors.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function.
排除标准
- •Patients must not have active brain metastases.
- •Patients must not have current or past history of central nervous system (CNS) involvement.
- •Patients must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
- •Patients must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places patients at unacceptable risk of participating in this study.
- •Patients must not have clinically significant cardiovascular disease.
- •Pregnant or lactating.
- •Conditions that could affect drug absorption.
研究组 & 干预措施
Single Agent
干预措施: TLN-372 (Drug)
Combination Treatment
干预措施: TLN-372 in combination with cetuximab (Drug)
Combination Treatment
干预措施: TLN-372 in combination with pembrolizumab (Drug)
结局指标
主要结局
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372
时间窗: Up to 2 years
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation.
时间窗: Up to 2 years
Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1
时间窗: Up to 2 years
次要结局
- Maximum observed plasma concentration (Cmax) of TLN-372(Up to 2 years)
- Time to peak drug concentration (Tmax) of TLN-372(Up to 2 years)
- Minimum observed plasma concentration (Cmin) of TLN-372(Up to 2 years)
- Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372(Up to 2 years)
- Anti-tumor activity of TLN-372 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression(Up to 2 years)
- Frequency of dose interruptions, reductions and dose intensity(Up to 2 years)
- Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0(Up to 2 years)
- Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0(Up to 2 years)