A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2026-05-23
Target enrollment:
Participant gender:
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 Cohort Expansion phase:The preliminary plan of cohort expansion phase uses the Simon
two-stage optimal method to expand 2 to 3 cohorts.