Clinical Trial of WBC100 on Advanced Solid Tumor

PHASE1RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 25, 2021

Primary Completion Date

October 25, 2025

Study Completion Date

October 25, 2025

Conditions
Solid Tumor
Interventions
DRUG

WBC100 QOD

"The first stage: single dose escalation according to classic 3+3 dose escalation method. 7 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. 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 3 weeks and off for 1 week.~The second stage: Two dose levels will be chosen according to data from the first stage. Each dose stage will enroll 12 c-myc-positive patients with a selected cancer type"

DRUG

WBC100 QD

"The first stage: single dose escalation according to classic 3+3 dose escalation method. 6 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 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. The second stage: Two dose levels will be chosen according to data from the first stage. Each dose stage will enroll 12 c-myc-positive patients with a selected cancer type"

DRUG

WBC100 BID

"The first stage: 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. 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; The second stage: Two dose levels will be chosen according to data from the first stage. Each dose stage will enroll 12 c-myc-positive patients with a selected cancer type"

Trial Locations (1)

310003

RECRUITING

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

All Listed Sponsors
lead

Zhejiang University

OTHER