NCT06172309已完成1 期
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamic Effect of NTQ1062 Tablets in Chinese Patients With Advanced Solid Tumors
Nanjing Chia-tai Tianqing Pharmaceutical2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年9月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is an open-label, single-arm, phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effect of NTQ1062 in patients with advanced solid tumors.
The study comprises a dose-escalation phase and a dose-expansion phase.
- Dose-escalation:using 3+3 design to evaluate the safety, tolerability, and pharmacokinetic profile of NTQ1062 at 20, 50, 100, 200, 300, 400 mg in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD).
- Dose-expansion:the dose-expansion study will evaluate the safety, tolerability, and preliminary pharmacodynamic effect of the MTD for NTQ1062 in patients with advanced solid tumors, and to identify the recommended phase 2 dose (RP2D).
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 at least 18 years old, male or female patients.
- •Patients with histologically and cytologically confirmed, advanced malignant solid tumors who have progressed on standard therapy or for whom no standard therapy exists, or for whom no standard treatment is available.
- •(Dose escalation phase)Solid tumors that are at least one evaluable per Response Evaluation Criteria in Solid Tumors(RECIST v1.1);(Dose expansion phase)Solid tumors that are at least one measurable per Response Evaluation Criteria in Solid Tumors(RECIST v1.1).
- •ECOG score is 0-
- •Predicted life expectancy ≥3 months.
- •Patients must have adequate organ function:
- •Absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count ≥ 75×109/L, hemoglobin ≥ 85 g/L.
- •Liver function: Total bilirubin ≤ 1.5xULN, AST and ALT ≤ 3.0xULN (≤ 5.0xULN for patients with Patients with hepatic metastases or hepatic carcinoma).
- •Renal function:Creatinine (Cr) ≤ 1.5xULN or creatinine clearance (Ccr) ≥ 50 ml/min/1.73m
- •Coagulation function: activated partial thromboplastin time (APTT) and INR ≤1.5×ULN.
- •Female patients of child-bearing potential, and all male partners must consent to use a acceptable method of contraception throughout the study period and for 90 days after the last dose of either study drug.
- •Patients must be signed written informed consent prior to admission to the study.
排除标准
- •Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- •Diagnosis of diabetes mellitus type I.
- •Baseline fasting glucose value of ≥8.33 mmol/l (150 mg/dL).
- •Glycosylated haemoglobin (HbA1C) ≥8%.
- •Patients who are still receive anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor drug from 4 weeks prior to the first dose.
- •Patients have received previous treatment with a AKT,PI3K or mTOR inhibitor.
- •Patients received strong inhibitors and/or inducers of CYP3A4 within 7 days prior to the first dose of study drug.
- •Active infection requiring systemic treatment.
- •Active hepatitis B virus infection or hepatitis C virus infection.
- •History of human immunodeficiency virus infection.
- •Patient has symptomatic CNS metastases.
- •History of severe cardiovascular diseases.
- •Other conditions that the investigator considers inappropriate for participation in this clinical trial
研究组 & 干预措施
NTQ1062
Experimental
NTQ1062 Tablets will be administered orally QD in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts.
干预措施: NTQ1062 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: First treatment cycle (i.e., the first 28 days post the first dose)
The MTD is defined as the highest dose reached for which the incidence of dose limiting toxicity (DLT) occurs in less than 1/3 of the subjects.
Recommended phase 2 dose (RP2D)
时间窗: First treatment cycle (i.e., the first 28 days post the first dose)
The RP2D of NTQ1062 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.
Adverse events
时间窗: through study completion, an average of 1 year
Safety and tolerability of NTQ1062. Incidence of adverse events.
次要结局
- Progression-free Survival(PFS)(through study completion, an average of 1 year)
- Pharmacokinetic parameters:Cmax(At the end of Cycle 1 (each cycle is 28 days))
- Pharmacokinetic parameters: Tmax(At the end of Cycle 1 (each cycle is 28 days))
- Pharmacokinetic parameters: AUC(At the end of Cycle 1 (each cycle is 28 days))
- Pharmacokinetic parameters:T1/2(At the end of Cycle 1 (each cycle is 28 days))
- Objective response rate (ORR)(through study completion, an average of 1 year)
- Disease Control Rate(DCR)(through study completion, an average of 1 year)
- Duration of Response(DOR)(through study completion, an average of 1 year)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
1 期
A Phase Ib/Ⅱ Study of NTQ1062 in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast CancerHR Positive/HER-2 Negative Breast CancerNCT06172322Nanjing Chia-tai Tianqing Pharmaceutical42
已完成
1 期
Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD3043HealthyNCT00918515AstraZeneca53
已完成
1 期
Phase 1 Study of IBR854 in Locally Advanced Or Metastatic Solid TumorsSolid TumorsNCT06001684Imbioray (Hangzhou) Biomedicine Co., Ltd.19
已完成
1 期
A Phase I Study Of JS015 in Patients With Advanced Solid TumorsAdvanced Solid CancerNCT05770310Shanghai Junshi Bioscience Co., Ltd.12
进行中（未招募）
1 期
The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant TumorAdvanced Malignant TumorNCT06022250Shanghai Junshi Bioscience Co., Ltd.98