drugset / Trial / NCT04283097
Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |