NCT06240546招募中1 期
A Phase I, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LPM6690176 Capsules in Patients With Advanced Solid Tumors.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of dose-limiting toxicities (DLTs)
研究概览
简要总结
This study is a phase 1, first-in-human, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and tolerability, pharmacokinetics characteristics and preliminary anti-tumor activity of LPM6690176 capsules in patients with advanced 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide a signed informed consent;
- •Age 18 ~ 75 years, male or female;
- •Patients with histologically or cytologically confirmed advanced or metastatic unresectable solid tumors, who failed or intolerant to standard anti-tumor therapy or lack of standard therapy;
- •According to RECIST 1.1 criteria,
- •Dose escalation phase: patients with at least one non-measurable lesion;
- •Dose expansion phase: patients with at least one measurable lesion;
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- •Life expectancy≥ 3 months;
- •Adequate bone marrow, liver, kidney, metabolism and coagulation function (blood transfusion, colony stimulating factors, albumin, and blood products are not allowed to use within 14 days before enrollment);
- •Negative pregnancy test within 7 days before first dose of study drug treatment in women of childbearing age. Female patients with childbearing potential were to use effective contraception during and for 6 months after the first dose of study drug treatment. Male patients (female partners with childbearing potential) should take effective contraceptive measures during study drug treatment and until 4 months after last dose of study drug administration.
排除标准
- •Patients who have not recovered from AEs caused by previous anti-tumor therapy to ≤ Grade 1 (assessed according to NCI-CTCAE 5.0 criteria, excluding alopecia and ≤ Grade 2 peripheral sensory neuropathy);
- •Pleural effusion, pericardial effusion, or ascites requiring medical intervention or frequent drainage within 1 month before signed informed consent decided by the investigator;
- •Symptomatic brain metastasis, history of spinal cord compression or leptomeningeal metastasis;
- •Concomitant Diseases:
- •Any of the following diseases within 6 months before the first dose of study treatment: myocardial infarction, unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, and serious arrhythmia requiring treatment;
- •Patients who require long-term anticoagulant therapy or anti-platelet therapy or require long-term use of non-steroidal anti-inflammatory drugs;
- •Patients with uncontrolled hypertension, hypertensive crisis or history of hypertensive encephalopathy;
- •Patients with increased risk of gastrointestinal ulcer or gastrointestinal bleeding tendency or gastrointestinal perforation tendency;
- •Patients with known active colitis within 8 weeks prior to screening, or diarrhea ≥4 times in 24 hours;
- •Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks before the first dose of study drug treatment;
- •HBsAg (+) and HBV DNA≥ 1×103 or HCV (+) or HIV (+);
- •Patients who have undergone major surgical procedures 4 weeks before the first dose of study drug treatment, or have severe injury, or requiring elective major surgery during the study, or have unhealed wounds, ulcers or fractures;
- •Exclusion criterion specific to dose expansion phase: patients who have any malignancy within 5 years before the first dose of study treatment except for the specific cancer under investigation in this study (cured carcinoma in situ of the cervix, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of breast ductal are eligible).
- •Prior Medications:
- •Patients who received anti-tumor therapy within 4 weeks before the first dose of study drug treatment;
- •Received LPM6690176 capsules or other PLK-1 inhibitors therapy before enrollment;
- •Received live attenuated vaccination within 4 weeks before signed informed consent;
- •Use of strong inducers or strong inhibitors of CYP3A4 within 2 weeks or 5 half-lives of the medication before the first dose of study drug treatment;
- •Use of medications mainly metabolized by CYP2B6 within 2 weeks or 5 half-lives (which takes longer time) of the medication before the first dose of study drug treatment;
- •Patients who may receive other systemic anti-tumor therapy or local radical therapy of target lesions/non-target lesions during the study;
- •History of drug abuse, drug addiction, or alcoholism;
- •Known hypersensitivity to any component of the study drug;
- •Patients who participated in other clinical trials and received treatment within 1 month;
- •Pregnant or lactating women;
- •Other conditions that may elevate the risk of the patient or interfere the study results decided by the investigator.
研究组 & 干预措施
2 mg/m2
Experimental
LPM6690176 capsules administered 2 mg/m2 on day 1-5 (qd) every two weeks.
干预措施: LPM6690176 (Drug)
4 mg/m2
Experimental
LPM6690176 capsules administered 4 mg/m2 on day 1-5 (qd) every two weeks.
干预措施: LPM6690176 (Drug)
8 mg/m2
Experimental
LPM6690176 capsules administered 8 mg/m2 on day 1-5 (qd) every two weeks.
干预措施: LPM6690176 (Drug)
16 mg/m2
Experimental
LPM6690176 capsules administered 16 mg/m2 on day 1-5 (qd) every two weeks.
干预措施: LPM6690176 (Drug)
24 mg/m2
Experimental
LPM6690176 capsules administered 24 mg/m2 on day 1-5 (qd) every two weeks.
干预措施: LPM6690176 (Drug)
36 mg/m2
Experimental
LPM6690176 capsules administered 36 mg/m2 on day 1-5 (qd) every two weeks.
干预措施: LPM6690176 (Drug)
48 mg/m2
Experimental
LPM6690176 capsules administered 48 mg/m2 on day 1-5 (qd) every two weeks.
干预措施: LPM6690176 (Drug)
结局指标
主要结局
Number of dose-limiting toxicities (DLTs)
时间窗: From the first dose of study drug treatment through Cycle 1 (28 days)
maximum tolerated dose (MTD) of LPM6690176
时间窗: From the first dose of study drug treatment through Cycle 1 (28 days)
次要结局
- Overall response rate (ORR)(Approximately 2 years)
- Overall survival (OS)(Approximately 3 years)
- Maximum plasma concentration(From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2 (28 days).)
- Time to maximum plasma concentration(From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2 (28 days).)
- Area under the plasma concentration-time curve(From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2 (28 days).)
- Elimination half-life(From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2 (28 days).)
- Duration of response (DOR)(Approximately 2 years)
- isease control rate (DCR)(Approximately 2 years)
- Progression-free survival (PFS)(Approximately 2 years)
研究者
研究点 (1)
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