KCT0009135尚未招募Unknown
A Single-center, Open-label, Dose-finding, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of IMP301 in Patients with Advanced/Metastatic Solid Tumors
IMGT0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Adult men and women over 19 years of age as of the date of consent.
- •2)Histologically or cytologically confirmed un-resectable locally advanced and/or metastatic solid tumor patient. Not responding to conventional standard treatment or have disease progression and No other available standard treatment exsist.
- •3)At least one measurable or non-measurable but evaluable lesion as per RECIST version 1.1
- •4)Estimated survivor period = 12 weeks
- •5)ECOG performance status = 1
- •6)Hematologic, kidney and liver functions.
- •?ANC = 1,500/mm3 without G-CSF application within 2weeks
- •?Platelet count = 100,000/mm3 without transfusion within 1week
- •?Hb = 9 g/dL without transfusion within 1week
- •?Serum creatinine (or creatinine clearance calculated with Cockcroft-Gault Equation) = 1.5 x ULN (= 60 mL/min)
- •?Total bilirubin = 1.5 x ULN (In Gilbert’s syndrome = 3.0 x ULN)
- •?AST = 3 x ULN (confirmed liver-metastasis or liver cell cancer = 5.0 x ULN)
- •?ALT = 3 x ULN(confirmed liver-metastasis or liver cell cancer = 5.0 x ULN)
- •?PT (INR) and aPTT = 1.5 × ULN (If on anti-coagulant, within the therapeutic range for intended use of anti-coagulant will be permitted)
- •7)Able to applicate Focused ultrasound system after IMP301 administration
- •8)Voluntary participant.
排除标准
- •1)Have any of the following comorbidities
- •?NYHA class III/IV heart failure
- •?LVEF < 50% on ECHO or MUGA
- •?Uncontrolled Hypertension (SBP/DBP = 140/90 mmHg)
- •?Uncontrolled cardiac arrhythmia
- •?Uncontrolled chronic systemic infectious disease
- •?Requiring treatment for pneumonia or respiratory symptoms such as dyspnea, cough, fever. Or other conditions prone to hypoxemia
- •?Clinically significant symptomatic or uncontrolled central nervous system metastases. (Except anticonvulsants or corticosteroids have been discontinued 2 weeks prior to IMP301 administration and have been clinically or imaging stable for at least 4 weeks.
- •?Active hepatitis B(HBsAg positive. However, HBsAg-positive patients may participate if they are stable on antiviral therapy.) or hepatitis C(HCV Ab positive. However, if HCV RNA test result is negative, participation is allowed)
- •?Clinically significant mental illness
- •2)At the time of the screening visit, have a history of
- •?Major surgery within 4weeks
- •?History of clinically significant gastrointestinal bleeding or that would affect pharmacokinetic evaluation within 12 weeks.
- •?History of drug or alcohol abuse within 12 weeks.
- •?Acute coronary syndrome within 24 weeks
- •?Medical history or pre-treatment cytogenetic test results at risk of MDS/AML diagnosis
- •?Known HIV infection
- •3)Received any of the following drug/non-drug therapies
- •?Use of systemic immunosuppressive agents within 2 weeks prior to Baseline (Cycle1Day1 dosing day), except for nasally administered, inhaled, topical, or locally injected (e.g., joint injections) corticosteroids.
- •?Any of the following anticancer therapies prior to Baseline (Cycle1Day1 dosing day),
- •i.Radiotherapy, chemotherapy, targeted therapy, hormonal therapy, or immunotherapy within 3 weeks (Except point radiation for the purpose of relieving bone pain, bronchial obstruction, skin lesions, etc.).
- •ii.Nitrosoureas or mitomycin-C within 6 weeks.
- •?Exceeding the cumulative dose of the following Anthracycline series drugs.
- •i.Non liposomal doxorubicin: 250 mg/m2
- •ii.Liposomal doxorubicin: 300 mg/m2
- •iii.Epirubicin: 400 mg/m2
- •4)Focused ultrasound system procedure is not applicable
- •?Cystic lesion in an organ adjacent to the solid cancer to be treated with Focused ultrasound system.
- •?Extensive scarring or surgical clips are observed in the pathway of the Focused ultrasound system beam
- •?Proper ultrasound image for Focused ultrasound system procedure is not available.
- •?Inability to lie down for the duration of the Focused ultrasound system application.
- •5)Adverse events after prior chemotherapy that have not recovered to CTCAE grade 1 or baseline status (except for alopecia (any grade), peripheral neuropathy (grade 2 or less), or meeting the eligibility criteria for this study).
- •6)CTCAE grade 3 or higher Hematologic toxicity after prior chemotherapy exceeding 4 weeks.
- •7)Predicted hypersensitivity to the major ingredient of IMP301 or any of its analogs, or who have experienced hypersensitivity(CTCAE criteria grade 3 or greater) on any of its analogs.
- •8)Received an investigational drug or medical device in another clinical trial within 4 weeks prior to IMP301 administration.
- •9)Pregnant or lactating women
- •10)Female/male subjects of childbearing potential who plan to become pregnant or who do not agree to practice adequate contraception* after IMP301 administration and for 6 months after termination of treatment.
- •*Adequate contraception:
研究者
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