drugset / Trial / NCT04283097

Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects

NCT04283097 ↗

Phase 1 Completed 30 enrolled Kangpu Biopharmaceuticals, Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a phase 1, multicenter, open-label, multiple-ascending dose study to evaluate the safety, pharmacokinetics and clinical activity of KPG-818 in subjects with hematological malignancies. Approximately 30 patients will be enrolled for dose escalation of 4 dose levels. Indication: Hematological malignancies (multiple myeloma \[MM\], mantle cell lymphoma \[MCL\], diffuse large B-cell lymphoma \[DLBCL\], adult T-cell leukemia-lymphoma \[ATL\], and indolent non Hodgkin lymphomas such as follicular lymphoma \[FL\] and chronic lymphocytic leukemia \[CLL\]/small lymphocytic lymphoma \[SLL\]).

Timeline

Start
2021-09-13
Primary completion
2024-12-12
Completion
2024-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject KPG-818 Unknown 2 mg Oral
Subject KPG-818 Unknown 3 mg Oral
Subject KPG-818 Unknown 4 mg Oral
Subject KPG-818 Unknown 5 mg Oral