Phase III Study of WJB001 Capsules to Assess Safety, Dosage, and Early Effects in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a Phase III study to evaluate the safety, tolerability, dose-limiting toxicity DLT, maximum tolerated dose MTD, and recommended Phase II dose RP2D of WJB001 capsules in patients with advanced solid tumors. The study includes multiple phases dose escalation, dose expansion, and cohort expansion, aiming to understand the drugs initial efficacy, safety, and pharmacokinetic characteristics. During the dose escalation phase, accelerated titration was used for the first two dose groups, followed by a Bayesian optimal interval BOIN combination method for later dose groups. In the dose expansion phase, one to two doses were selected based on previous data to confirm the RP2D and further evaluate efficacy and safety. The cohort expansion phase plans to expand two to three patient groups using the Simon two-stage optimal method. Participants will undergo screening, treatment, and follow-up periods. Researchers will assess dose-limiting toxicities over 21 days and monitor adverse events, serious adverse events, objective response rate, and survival outcomes for up to three years. Pharmacokinetic measurements including peak time, plasma concentration, clearance rate, and half-life will be collected at specific time points during treatment cycles. This extensive monitoring aims to understand WJB001s effects and determine appropriate dosing for future studies.

A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors