Clinical Trial of WBC100 on Advanced Solid Tumor

Last updated: December 21, 2024
Sponsor: Zhejiang University
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Neuroblastoma

Treatment

WBC100 QD

WBC100 BID

WBC100 QOD

Clinical Study ID

NCT05100251
WBC100
  • Ages 18-75
  • All Genders

Study Summary

This is a phase I clinical study of WBC100 in Patients with advanced solid tumor.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sign informed consent, able to follow protocol requirements;

  2. Aged 18 to 75 years, male or female

  3. (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.

  4. ECOG Performance Status score: 0 to 2 points

  5. Expected survival is > 3 months

  6. Adequate hematologic and organ functions (without persistent supportive treatment)

  7. Absolute Neutrophil Count > 1.5 × 109/L, Platelet count ≥ 75 × 109/L,Hemoglobin > 8.5 g/dL

  8. INR and PT ≤ 2 × ULN

  9. ALB > 3.0 g/dL, Bilirubin level ≤ 2 × ULN, AST and ALT ≤ 2 × ULN or < 5 × ULNin the presence of liver metastases

  10. 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

  11. According to RECIST 1.1, patients have at least one evaluable target lesion(only fordose expansion stage)

  12. 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:

  1. Allergic to WBC100 or its excipients or with allergic constitution

  2. Major surgery, active ulcer or unhealing wound occurred within 4 weeks before firstdose

  3. Taken drugs in other clinical trials within 4 weeks or still in the safety follow-upperiod

  4. 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)

  5. Subjects have history of cardiac insufficiency (NYHA III-IV) or uncontrolledcongestive heart failure (NYHA II-IV) within 6 months before consent

  6. Subjects have risk factors of QT intervals prolongation or arrhythmia, such asIdiopathic Q-T interval prolongation syndrome or history of drug induced arrhythmia

  7. 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

  8. Infection of HIV, active infection of HBV (HBV DNA > 1000 IU/ml) active infection ofHC (HCV-RNA ≥ upper limits of normal)

  9. History of severe infection within 28 days before enrolled, including uncontrolledinfection requiring systemic treatment of bacteria, virus and fungus

  10. 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

  11. 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

  12. Subjects taking any strong CYP inducers or inhibitors or Chinese medicine within 7days prior to the first dose of study drug

  13. 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

  14. Subjects who have antitumor therapy within 28 days prior to first dose of WBC100,such as monoclonal antibody, chemotherapy, radiotherapy and Chinese medicine

  15. Subjects have mental disorders or history of drug abuse that may limit subjects'participation in this trial

  16. Unable to tolerate intravenous blood collection

  17. According to the investigators' evaluation, patients are unable or unwilling tocomply with the requirements of the study protocol

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: WBC100 QD
Phase: 1
Study Start date:
October 25, 2021
Estimated Completion Date:
October 25, 2025

Study Description

This is a phase I open-label, single and 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.

Connect with a study center

  • the First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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