A PhaseⅠ Study Explore WJ01075 Tablets in Patients With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2026-06-06
Target enrollment:
Participant gender:
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.