A Phase 1/2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Phase 1: Number of dose-limiting toxicity (DLT)
研究概览
简要总结
This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
详细描述
This is a Phase 1/2a, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary efficacy of NTS071 in subjects with unresectable locally advanced or metastatic solid tumors containing a TP53 Y220C mutation.
This study includes two parts: Phases 1 and 2a. The Phase 1 part consists of the dose escalation and backfill part; The Phase 2a part consists of the cohort expansion part.
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
- •Male or female subjects, ≥ 18 years
- •Advanced solid tumors with TP53 Y220C mutation
- •Previously treated with one or more lines of anticancer therapy and progressive disease
- •At least one measurable lesion according to RECIST version 1.1 criteria
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Adequate organ and bone marrow function
排除标准
- •Known CNS primary tumor and active or untreated CNS metastases
- •History of another primary malignancy that has been diagnosed or required therapy within the past 2 years
- •Toxicities of prior therapy have not been resolved to ≤ Grade 1 or to baseline
- •Significant cardiovascular disease, including congestive heart failure
- •Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active
- •Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
研究组 & 干预措施
NTS071
Single arm
干预措施: NTS071 (Drug)
结局指标
主要结局
Phase 1: Number of dose-limiting toxicity (DLT)
时间窗: The first 26 days of treatment (Cycle 1) per patient
Incidence of dose-limiting toxicity (DLT) events
Phase 1: incidence of adverse events (AE), serious adverse events (SAEs)
时间窗: up to 30 days after the last administration
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Phase 2a: Overall Response Rate (ORR)
时间窗: Up to 3 years
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
次要结局
- Phase 1/2a: disease control rate (DCR)(Up to 3 years)
- Phase 1/2a: maximum concentration (Cmax)(Up to 2 years)
- Phase 1/2a: half-life (t1/2) of NTS071(Up to 2 years)
- Phase 1/2a: trough observed concentrations (Ctrough/Ctau)(Up to 2 years)
- Phase 1: Objective response rate (ORR)(Up to 3 years)
- Phase 1/2a: duration of response (DoR)(Up to 3 years)
- Phase 1/2a: progression-free survival (PFS)(Up to 3 years)
- Phase 1/2a: Overall survival (OS)(Up to 3 years)
- Phase 1/2a: area under the curve (AUC)(Up to 2 years)