drugset / Trial / NCT05495035
Study for Safety and Efficacy of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Ph + ALL
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, phase 1b study, which is designed to explore the safety, efficacy and PK of olverembatinib, a third-generation tyrosine kinase inhibitor (TKI) marketed in China, in combination with APG-2575 in treating R/R Ph+ALL children, and to preliminarily establish the recommended dose of olverembatinib and APG-2575 for children based on the above results.
Timeline
- Start
- 2022-09-01
- Primary completion
- 2024-08-31
- Completion
- 2024-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APG-2575 | Small molecule | 600 mg | Oral |
| Subject | Olverembatinib | Small molecule | 40 mg | Oral |
| Background | Dexamethasone | Small molecule | 6 mg/m2 | Oral |