NCT05100251终止1 期
An Open, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WBC100 in Patients With Advanced Solid Tumor
Zhejiang University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年12月17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
- 终止
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Event and Severe Adverse Event
研究概览
简要总结
This is a phase I clinical study of WBC100 in patients with advanced solid tumor.
详细描述
This is a phase I open-label, dose escalation study to evaluate the safety, pharmacokinetics, and preliminary efficacy of WBC100, a drug targeting c-myc, in subjects who have been diagnosed with c-myc positive advanced solid tumor and refractory or intolerant to current standard systemic treatment.
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
- •Sign informed consent, able to follow protocol requirements；
- •Aged 18 to 75 years, male or female
- •（1）Dose escalation stage: Histopathology or cytology proven patients with advanced solid tumor with positive C-myc expression who have developed progressive disease or intolerability after at least one line of standard systemic therapies.（2）Dose expansion stage: Histopathology or cytology proven patients with advanced solid tumor of a selected cancer type with positive C-myc expression who have developed progressive disease or intolerability after at least one line of standard systemic therapies. Positive C-myc refers to more than 1% tumor cells are detected 1+ by immunohistochemistry (IHC) in histologic section.
- •ECOG Performance Status score: 0 to 2 points
- •Expected survival is > 3 months
- •Adequate hematologic and organ functions (without persistent supportive treatment)
- •Absolute Neutrophil Count > 1.5 × 109/L, Platelet count ≥ 75 × 109/L, Hemoglobin > 8.5 g/dL
- •INR and PT ≤ 2 × ULN
- •ALB > 3.0 g/dL, Bilirubin level ≤ 2 × ULN, AST and ALT ≤ 2 × ULN or < 5 × ULN in the presence of liver metastases
- •Calculated creatinine clearance (e.g. Cockcroft-Gault) ≥ 60 ml/min or serum creatinine ≤ 1.5 × ULN
- •f. Left ventricular ejection fraction (LVEF) ≥ 50%. Heart rate (HR) ≥ 60 bpm. QT intervals, male ≤ 450 ms, female ≤ 470 ms
- •According to RECIST 1.1, patients have at least one evaluable target lesion(only for dose expansion stage)
- •Female patients of child-bearing potential or male subjects whose spouses are women of childbearing potential must agree to use a reliable method of contraception (IUD, oral contraceptive, condom) throughout the treatment period and for 3 months after discontinuation of WBC
- •Female patients of child-bearing age must undergo a serum pregnancy test before the initiation of the study and the result must be negative.
排除标准
- •Allergic to WBC100 or its excipients or with allergic constitution
- •Major surgery, active ulcer or unhealing wound occurred within 4 weeks before first dose
- •Taken drugs in other clinical trials within 4 weeks or still in the safety follow-up period
- •Subjects have Spinal compression, brain metastases and meningeal metastases (subjects who is asymptomatic, stable or with no need for steroid for at least 4 weeks before first dose are allowed)
- •Subjects have history of cardiac insufficiency (NYHA III-IV) or uncontrolled congestive heart failure (NYHA II-IV) within 6 months before consent
- •Subjects have risk factors of QT intervals prolongation or arrhythmia, such as Idiopathic Q-T interval prolongation syndrome or history of drug induced arrhythmia
- •Subject have any condition within 6 months before consent: unstable angina pectoris requiring surgical intervention, uncontrolled hypertension (systolic pressure ≥ 140 mmHg, diastolic pressure ≥ 90 mmHg), myocardial infarction, stroke (lacunar infarction is allowed), Coronary/peripheral artery bypass surgery, pulmonary embolism
- •Infection of HIV, active infection of HBV (HBV DNA > 1000 IU/ml) active infection of HC (HCV-RNA ≥ upper limits of normal)
- •History of severe infection within 28 days before enrolled, including uncontrolled infection requiring systemic treatment of bacteria, virus and fungus
- •The side effects caused by the previous treatment of the subjects did not return to grade ≤1 according to CTCAE 5.0 with exception of tolerable events determined by investigator such as hair loss and grade 2 Peripheral neuropathy
- •Subjects with uncontrolled nausea or vomiting, chronic gastrointestinal diseases, unable to swallow pills, enterostomy, uncontrolled diarrhea or any intestinal surgery that cause insufficient absorption of WBC100
- •Subjects taking any strong CYP inducers or inhibitors or Chinese medicine within 7 days prior to the first dose of study drug
- •History of malignancy in the last 2 years with the exception of patients with prior history of in situ breast cancer, in situ cervical cancer, basal or squamous cell skin cancer who have already been cured
- •Subjects who have antitumor therapy within 28 days prior to first dose of WBC100, such as monoclonal antibody, chemotherapy, radiotherapy and Chinese medicine
- •Subjects have mental disorders or history of drug abuse that may limit subjects' participation in this trial
- •Unable to tolerate intravenous blood collection
- •According to the investigators' evaluation, patients are unable or unwilling to comply with the requirements of the study protocol
研究组 & 干预措施
Once every other day (QOD)
Experimental
(1) Once every other day (QOD): after a single-dose administration (C0) and 2-day washout period, subjects will start receiving multiple doses, for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle
干预措施: WBC100 QOD (Drug)
Twice daily (BID)
Experimental
(2) Twice daily (BID): dosing for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle;
干预措施: WBC100 BID (Drug)
Once daily (QD)
Experimental
Once daily (QD): dosing 3 consecutive weeks (with QD dosing for the first 5 days of each week followed by a 2-day rest), followed by a 1-week rest period, with a 4 weeks as one cycle
干预措施: WBC100 QD (Drug)
结局指标
主要结局
Frequency of Adverse Event and Severe Adverse Event
时间窗: 2 years
AEs and SAEs will be assessed by CTCAE v5.0
Maximum Tolerated Dose（MTD）
时间窗: 28 days
The highest dose level at which \< 2 of 6 subjects experienced a dose limiting toxicity during the first 28 days of the treatment period
Dose limited toxicity（DLT）
时间窗: 28 days
safety
次要结局
- Duration of response (DOR)(2 years)
- Tmax(28 days)
- AUC0-inf(28 days)
- Vz/F(28 days)
- Cmax(28 days)
- T1/2(28 days)
- Cmin, ss(28 days)
- λz(28 days)
- Cmax, ss(28 days)
- Cavg(28 days)
- Tmax, ss(28 days)
- CLss/F(28 days)
- Vss/F(28 days)
- ARCmax(28 days)
- Serum ferritin(28 days)
- Progression-free survival (PFS)(2 years)
- Objective response rate (ORR)(2 years)
- AUC0-t(28 days)
- CL/F(28 days)
- DF(28 days)
- CA125(28 days)
- change of tumor size(52 weeks)
- ARAUC(28 days)
- CA19-9(28 days)
研究者
TingBo Liang
Professor
First Affiliated Hospital of Zhejiang University
研究点 (1)
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