KCT0006514招募中未知
An Open-label, Dose-finding, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of DNP002 in Patients with Advanced Solid Tumors
KumhoHT0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Males and females 19 years of age or older as of the date of written consent
- •2)Locally advanced and/or metastatic unresectable solid tumor that is histologically or cytologically confirmed and is unresponsive to the conventional standard therapy, has progressed, and has no other standard treatment options available
- •3)At least one or more measurable or unmeasurable but evaluable lesion in accordance with the response evaluation criteria in solid tumors (RECIST) version 1.1
- •4)Anticipated survival of 12 weeks or longer
- •5)Eastern cooperative oncology group (ECOG) performance status = 1
- •6)Confirmation of appropriate hematological, renal, and hepatic functioning based on the following criteria (laboratory tests can be re-performed during the screening period):
- •Laboratory endpoint Required limit for inclusion
- •Absolute neutrophil count (ANC) = 1,500/mm3
- •Hemoglobin (Hb) = 8 g/dL
- •Platelet count = 100,000/mm3
- •Total bilirubin = 1.5 x upper limit of normal (ULN)
- •(for Gilbert’s syndrome, = 3.0 × ULN)
- •Aspartate aminotransferase (AST) and = 3 × ULN
- •alanine amin transferase (ALT) (for liver metastasis or hepatocellular carcinoma, = 5.0 × ULN)
- •Alkaline phosphatase (ALP) = 2.5 × ULN
- •(for liver or bone metastasis, = 5.0 × ULN)
- •Serum creatinine (or creatinin
- •clearance [CrCL]) = 1.5 × ULN
- •(= 60 mL/min)
- •7) Recovery from reversible side effects of previous anticancer therapies to a state equivalent to grade 1 of the national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or baseline status (subjects with hair loss [regardless of grade], grade 2 or lower peripheral neuropathy, or appropriate laboratory test results as per inclusion/exclusion criteria can be enrolled)
- •8) For females with childbearing potential, a negative pregnancy test (urine hCG and/or serum hCG) at the time of clinical trial participation
- •9) Fertile females and males who have no plans to conceive starting from the screening to 24 weeks after completion of administration and who are willing to use proper contraceptives*
- •*? Hormonal contraceptives, ? intrauterine device or intrauterine implant, ? use of a double contraceptive technique (use of both a condom and vaginal diaphragm or cervical cap), or ? sterilization procedure (vasectomy, bilateral tubal ligation)
- •10) Voluntary written consent to participate in this clinical trial
排除标准
- •Subjects who meet any of the following criteria are excluded from the trial:
- •1)Any one of the following comorbidities at the screening visit:
- •(1)Hematological malignancy, including lymphoma
- •(2)Interstitial lung disease or pulmonary fibrosis
- •(3)Bowel obstruction or bowel perforation
- •(4)Clinically significant pericardial fluid, pleural effusion fluid, or ascites
- •(5)Severe infections or other uncontrolled active infectious diseases that require the use of antibiotics and antiviral agents that are deemed by the investigator to potentially affect the safety and efficacy assessments during the study period
- •(6)Uncontrolled hypertension (systolic blood pressure [SBP]/diastolic blood pressure [DBP] = 160/100 mmHg),
- •(7)QTc interval > 480 msec* (same criteria for males and females)
- •*Fridericia’s QT correction formula
- •(8)Active hepatitis B or C (subjects who test positive for hepatitis C virus antibody [HCV Ab] but negative for HCV ribonucleic acid [RNA] are considered to have had a prior infection and thus can participate in the clinical trial)
- •(9)Clinically significant symptoms, uncontrolled central nervous system (CNS) or brain involvement, or carcinomatous meningitis (However, subjects treated for CNS or brain metastasis with a confirmed lack of clinical progression or progression via CT/MRI for at least 4 weeks prior to study drug administration and who do not require steroid therapy 2 weeks prior to study drug administration can be enrolled)
- •2)Medical history (including surgery/procedure history) with any of the following at the screening visit:
- •(1)Major surgery or clinically significant traumatic injury within 4 weeks prior to screening
- •(2)Significant cardiovascular diseases, such as unstable angina, myocardial infarction, congestive heart failure, stroke, and unstable arrhythmia within 24 weeks prior to screening
- •(3)Immunosuppressive disorder (e.g., acquired immune deficiency syndrome [AIDS] human immunodeficiency virus [HIV]) or autoimmune disease
- •(4)Mental illness that significantly affects the clinical trial as determined by the investigator
- •3)Use of any of the following pharmacological (pharmacological/non-pharmacological) therapies:
- •(1)Use of immunosuppressants within 2 weeks prior to baseline (D1) (Exception: local, topical, intraarticular, or intranasal corticosteroids, prednisolone at 10 mg/day, or systemic corticosteroids of an equivalent or lower dose)
- •(2)Other anticancer therapies involving other drugs and cancer immunotherapeutic agents within 3 weeks prior to baseline (D1)* (However, point radiation to reduce bone pain and improve bronchial obstruction and skin lesions are permitted; subjects with a history of nitrosoureas or mitomycin-C within 6 weeks prior to baseline are excluded from the trial)
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