drugset / Trial / NCT04807881

Phase Ib Clinical Study of Keynatinib

NCT04807881 ↗

Phase 1 Recruiting 75 enrolled Medolution Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, PK characteristics in subjects with relapsed/refractory B-cell lymphoma. Furthermore, the relationship between the exposure level of Keynatinib and its efficacy and safety, the penetration rate of keynatinib in the Blood-Brain Barrier (BBB) and its PK characteristics in cerebrospinal fluid in R/R-PCNSL patients, the relationship between the BTK receptor occupancy rate and the efficacy are also evaluated.

Timeline

Start
2020-09-24
Primary completion
2027-10-10
Completion
2028-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Keynatinib Unknown 20 mg Oral