WJB001

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.

1）I 期（剂量递增和剂量扩展阶段）：评估 WJB001 联合用药在晚期实体瘤患者中的安全性与耐受性、PK特性及初步疗效； 2）II期（疗效拓展阶段）：评估 WJB001 联合用药在目标瘤种如高级别浆液性卵巢癌、输卵管癌及腹膜癌、子宫浆液性癌患者的有效性、安全性和耐受性；