NCT05773820

A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of WJB001 Capsules in Dose Escalation, Dose Expansion, and Efficacy Expansion in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Wigen Biomedicine Technology (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II study to evaluate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJB001 capsules in patients with advanced solid tumors, including dose escalation phase, dose expansion phase and cohort expansion phase.The study includes screening, treatment and follow-up periods. In the Dose Escalation phase:Accelerated titration (the first two dose groups) and "BOIN" combination (the subsequent dose group) were used for dose escalation. In the Dose Expansion phase:Based on the previous data, 1 to 2 doses were selected to further evaluate the initial efficacy, safety, tolerability and pharmacokinetic characteristics to confirm RP2D. In the Efficacy Expansion phase:The preliminary plan of Efficacy expansion phase uses the Simon two-stage optimal method to expand 2 to 3 cohorts.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	WJB001	WJB001 Capsules:160mg(or othe dosages),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies,Every 21 days

Timeline

• Start date: 2023-05-05
• Primary completion: 2026-08-08
• Completion: 2027-05-23
• First posted: 2023-03-17
• Last updated: 2026-04-01

Locations

11 sites across 1 country: China