Phase
Condition
Neoplasms
Neuroblastoma
Treatment
WBC100 QD
WBC100 BID
WBC100 QOD
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 advancedsolid tumor with positive C-myc expression who have developed progressive disease orintolerability after at least one line of standard systemic therapies.(2)Doseexpansion stage: Histopathology or cytology proven patients with advanced solidtumor of a selected cancer type with positive C-myc expression who have developedprogressive disease or intolerability after at least one line of standard systemictherapies. Positive C-myc refers to more than 1% tumor cells are detected 1+ byimmunohistochemistry (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 × ULNin the presence of liver metastases
Calculated creatinine clearance (e.g. Cockcroft-Gault) ≥ 60 ml/min or serumcreatinine ≤ 1.5 × ULN f. Left ventricular ejection fraction (LVEF) ≥ 50%. Heart rate (HR) ≥ 60 bpm. QTintervals, male ≤ 450 ms, female ≤ 470 ms
According to RECIST 1.1, patients have at least one evaluable target lesion(only fordose expansion stage)
Female patients of child-bearing potential or male subjects whose spouses are womenof childbearing potential must agree to use a reliable method of contraception (IUD,oral contraceptive, condom) throughout the treatment period and for 3 months afterdiscontinuation of WBC100. Female patients of child-bearing age must undergo a serumpregnancy test before the initiation of the study and the result must be negative.
Exclusion
Exclusion Criteria:
Allergic to WBC100 or its excipients or with allergic constitution
Major surgery, active ulcer or unhealing wound occurred within 4 weeks before firstdose
Taken drugs in other clinical trials within 4 weeks or still in the safety follow-upperiod
Subjects have Spinal compression, brain metastases and meningeal metastases (subjects who is asymptomatic, stable or with no need for steroid for at least 4weeks before first dose are allowed)
Subjects have history of cardiac insufficiency (NYHA III-IV) or uncontrolledcongestive heart failure (NYHA II-IV) within 6 months before consent
Subjects have risk factors of QT intervals prolongation or arrhythmia, such asIdiopathic Q-T interval prolongation syndrome or history of drug induced arrhythmia
Subject have any condition within 6 months before consent: unstable angina pectorisrequiring surgical intervention, uncontrolled hypertension (systolic pressure ≥ 140 ≥ 90 mmHg), myocardial infarction, stroke (lacunarinfarction is allowed), Coronary/peripheral artery bypass surgery, pulmonaryembolism
Infection of HIV, active infection of HBV (HBV DNA > 1000 IU/ml) active infection ofHC (HCV-RNA ≥ upper limits of normal)
History of severe infection within 28 days before enrolled, including uncontrolledinfection requiring systemic treatment of bacteria, virus and fungus
The side effects caused by the previous treatment of the subjects did not return tograde ≤1 according to CTCAE 5.0 with exception of tolerable events determined byinvestigator 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 intestinalsurgery that cause insufficient absorption of WBC100
Subjects taking any strong CYP inducers or inhibitors or Chinese medicine within 7days prior to the first dose of study drug
History of malignancy in the last 2 years with the exception of patients with priorhistory of in situ breast cancer, in situ cervical cancer, basal or squamous cellskin 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 tocomply with the requirements of the study protocol
Study Design
Study Description
Connect with a study center
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting

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