A Phase 1 interventional study of WBC100 QOD and WBC100 QD in Solid Tumor, sponsored by Zhejiang University. Terminated at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Zhejiang University · Phase 1, Interventional, and Treatment
This is a phase I clinical study of WBC100 in patients with advanced solid tumor.
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.
Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate hematologic and organ functions (without persistent supportive treatment)
f. Left ventricular ejection fraction (LVEF) ≥ 50%. Heart rate (HR) ≥ 60 bpm. QT intervals, male ≤ 450 ms, female ≤ 470 ms
Exclusion Criteria:
(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
Drug: WBC100 QOD
(2) Twice daily (BID): dosing for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle;
Drug: WBC100 BID
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
Drug: WBC100 QD
The first stage: single dose escalation according to classic "3+3" dose escalation method. 9 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 0.5 mg QOD. The second dose group is 1mg QOD. The third dose group is 1.5 mg QOD. The fourth dose group is 2.0 mg QOD. The fifth dose group is 2.5 mg QOD. The sixth dose group is 3.0 mg QOD. The seven dose group is 3.5 mg QOD. The 8th dose group is 4.0 mg QOD. The 9th dose group is 4.5 mg QOD. In each dose group, patients take WBC100 once on cycle 0. After a washout period of 2 days, patents start subsequent 4 weeks cycles until progression disease or intolerable toxicity. In each cycle, patient was on WBC100 every for 2 weeks and off for 1 week. The second stage: One dose levels was chosen according to data from the first stage. 16 c-myc-positive patients with pancreatic cancer was enrolled
Single dose escalation according to classic "3+3" dose escalation method. 5 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 1.0 mg QD. The second dose group is 1.5 mg QD. The third dose group is 2.0 mg QD. The fourth dose group is 2.5 mg QD. The fifth dose group is 3.0 mg QD. In each dose group, the patient was on WBC100 until progression disease or intolerable toxicity. Patient was on WBC100 every for for 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.
Single dose escalation according to classic "3+3" dose escalation method. 4 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 0.5 mg QD. The second dose group is 1mg QD. The third dose group is 1.5 mg QD. The fourth dose group is 2.0 mg QD. The fifth dose group is 2.5 mg QD. The sixth dose group is 3.0 mg QD. In each dose group, the patient was on WBC100 until progression disease or intolerable toxicity. Patient was on WBC100 every for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle.
Frequency of Adverse Event and Severe Adverse Event
AEs and SAEs will be assessed by CTCAE v5.0
Time frame: 2 years
Dose limited toxicity（DLT）
safety
Time frame: 28 days
Maximum Tolerated Dose（MTD）
The highest dose level at which \< 2 of 6 subjects experienced a dose limiting toxicity during the first 28 days of the treatment period
Time frame: 28 days
Cmax
Peak plasma concentration after one dose
Time frame: 28 days
Tmax
Time to peak plasma concentration after one dose
Time frame: 28 days
AUC0-t
Area under the plasma concentration versus time curve after one dose and multiple dose；time range from 0 to last point when plasma concentration is detectable
Time frame: 28 days
AUC0-inf
Area under the plasma concentration versus time curve；time range from 0 to infinity
Time frame: 28 days
T1/2
half-life period
Time frame: 28 days
λz
elimination rate constant
Time frame: 28 days
CL/F
apparent clearance
Time frame: 28 days
Vz/F
apparent volume of distribution
Time frame: 28 days
Cmax, ss
Steady peak plasma concentration after multiple dose
Time frame: 28 days
Cmin, ss
Steady minimal plasma concentration after multiple dose
Time frame: 28 days
Cavg
Steady averagel plasma concentration after multiple dose
Time frame: 28 days
Tmax, ss
Time to steady peak plasma concentration after multiple dose
Time frame: 28 days
CLss/F
steady apparent clearance
Time frame: 28 days
Vss/F
steady apparent volume of distribution
Time frame: 28 days
ARCmax
Peak concerntration cumulative coefficient
Time frame: 28 days
ARAUC
AUC cumulative coefficient
Time frame: 28 days
DF
degree of fluctuation
Time frame: 28 days
CA19-9
Change of CA19-9
Time frame: 28 days
CA125
Change of CA125
Time frame: 28 days
Serum ferritin
change of serum ferritin
Time frame: 28 days
Progression-free survival (PFS)
The period from the day when the subject receives the first study treatment to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first
Time frame: 2 years
Duration of response (DOR)
The period from the first evaluation of complete response ( CR) or partial response (PR) to the first evaluation of progressive disease (PD)or death of any cause
Time frame: 2 years
Objective response rate (ORR)
The number of cases in which tumor size is reduced to partial response (PR) or complete response (CR) / the total number of evaluable cases (%). In the event of partial response( PR) or complete response (CR), the subjects should confirm it no less than 4 weeks after the first evaluation
Time frame: 2 years
change of tumor size
The major axis change of target lesion relative to baseline
Time frame: 52 weeks
Plan to share: No
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This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Zhejiang University