Spots Global Cancer Trial Database for A Study of WJ05129 in Advanced Malignant Solid Tumors
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Trial Identification
Brief Title: A Study of WJ05129 in Advanced Malignant Solid Tumors
Official Title: A Phase I/II Clinical Study of WJ05129 Tablets in Patients With Locally Advanced or Metastatic Malignant Solid Tumors
Study ID: NCT05326035
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Institute & Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Contact Details
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