A Study Explore WJ01075 Tablets in Patients With Advanced Solid Tumors

Summary

This is a phase I study to Investigate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJ01075 tablets in patients with advanced malignant solid tumors, including phase Ia (dose escalation phase) and Phase Ib (dose expansion phase,cohort expansion phase).The study includes screening, treatment and follow-up periods. In phase Ia, accelerated titration (the first two dose groups) and "3 + 3" combination (the subsequent dose group) were used for dose escalation. In phase Ib, specific dose groups will be selected for dose expansion according to PK(Pharmacokinetics) and safety data of different dose groups in dose escalation phase.It is planned that SMC(Safety Monitoring Committee) will select one or more dose groups based on previous data for cohort expansion studies to further determine RP2D, safety tolerability and initial efficacy.

Timeline

Start

2022-08-23

Primary completion

2023-04-18

Completion

2023-04-18

Outcome

Outcome not reported

Stopped (Business): “Terminate the study and close the research center based on strategic changes in product development, unrelated to drug safety.”

Drugs

Indications