A Study of WJ05129 in Advanced Malignant Solid Tumors
Status:
Not yet recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
This study was an open, multicenter Phase I/II clinical study of WJ05129 in patients with
locally advanced or metastatic malignant solid tumors in China, which was divided into three
stages: dose escalation, dose extension and efficacy extension. The study included screening,
treatment and follow-up periods. Dose escalation phase: adopt "3 + 3" dose escalation mode,
preset 5 dose groups: 1.25mg, 2.5mg, 5mg, 7.5mg, 10mg, oral, twice a day (only once on the
first day), planned to include a maximum of 30 subjects; Dose expansion phase: 2 dose groups
will be planned in this phase, and the specific dose will be determined according to the
trial data in the dose escalation phase. The maximum number of participants in each dose
group will be 12. Efficacy expansion phase: It is preliminarily planned to expand three
cohorts of Rb negative TNBC and SCLC and NB with high Myc expression, and recruit about 24
people in each cohort.