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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Locally Advanced or Metastatic Malignant Solid Tumors
  • Neoplasms

NCT number NCT05326035
Study type Interventional
Source Suzhou Junjing BioSciences Co., Ltd.
Contact Hongkai Wang
Phone 18911866139
Email hongkai_wang@junshipharma.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date April 30, 2022
Completion date June 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04225117 - A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) Phase 2