BR101801 in Adult Patients With Advanced Hematologic Malignancies(Phase I)
Summary
This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia, Phase Ib). The Phase Ia (dose escalation) part of the study is designed to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose for expansion (RP2D) of BR101801 in subjects with relapsed/refractory B cell lymphoma, chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), and peripheral T cell lymphoma (PTCL). The Phase Ib (dose expansion) part of the study is designed to assess tumor response and safety in specific advanced relapsed/refractory Peripheral T-cell lymphoma(PTCL) at a dose of BR101801 identified in Phase Ia. Once the RP2D has been determined in Phase Ia (dose escalation), Phase Ib (dose expansion) will commence.
Timeline
- Start
- 2020-04-21
- Primary completion
- 2023-09-21
- Completion
- 2023-09-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bosmolisib | Small molecule | 50 mg | Oral |
| Subject | Bosmolisib | Small molecule | 100 mg | Oral |
| Subject | Bosmolisib | Small molecule | 200 mg | Oral |
| Subject | Bosmolisib | Small molecule | 325 mg | Oral |
| Subject | Bosmolisib | Small molecule | 450 mg | Oral |