NCT05100251

Clinical Trial of WBC100 on Advanced Solid Tumor

An Open, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WBC100 in Patients With Advanced Solid Tumor

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	WBC100 QOD	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
DRUG	WBC100 QD	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.
DRUG	WBC100 BID	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.

Timeline

• Start date: 2021-12-17
• Primary completion: 2026-01-06
• Completion: 2026-01-06
• First posted: 2021-10-29
• Last updated: 2026-02-17

Locations

1 site across 1 country: China