Clinical Trial

A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors

Recruiting Phase 1/2

Record status

This record was last updated April 1, 2026 (before its estimated August 8, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2023-03-15; most recent amendment 2026-03-26.

Status change: Enrolling by Invitation → Recruiting 2025-02-06

Status change: Not Yet Recruiting → Enrolling by Invitation 2023-05-08

Trial Details

NCT Number	NCT05773820
Lead Sponsor	Wigen Biomedicine Technology (Shanghai) Co., Ltd. Collaborators: Sponsor GmbH
Conditions	Advanced Solid Tumors
Enrollment	210 participants
Start Date	2023-05-05
Primary Completion	2026-08-08 (estimated)
Study Completion	2027-05-23 (estimated)
Updated on ClinicalTrials.gov	2026-04-01