Mature B-cell Neoplasms Clinical Trial
Official title:
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms
There are two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion
stage (stage 2).
Dose-escalation stage (stage 1):
The conventional 3+3 design (3 patients per dose cohort, with the potential to add additional
3 patients to the same cohort to further evaluate toxicity) will be applied for dose
escalation and maximum tolerated dosage determination. Approximately 27 to 42 dose limited
toxicities evaluable patients will be enrolled. The actual number of patients depends on the
dose limited toxicities situation as well as the maximum tolerated dosage reached at this
stage.
Dosing will begin at 200mg once daily. A cycle of study treatment will be defined as 28 days
of continuous dosing.
Dose-expansion stage (stage 2):
This phase is to further evaluate the safety, the pharmacokinetics and anti-tumor activity of
HMPL-523 at recommended phase 2 dosage in approximately 190 patients with relapsed or
refractory Hematologic Malignancies.
In this stage, approximately 190 patients with Mature B-cell Neoplasms will be enrolled with
recommended phase 2 dosage 600milligram(mg) one a day(QD) as starting dosing. The tumor types
of the expansion stage are restricted to Chronic lymphocytic leukemia/ small lymphocytic
lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Follicular Lymphoma (FL), Diffuse large
B-cell lymphoma (DLBCL), Marginal zone lymphoma (MZL)and Waldenstrom's macroglobulinemia
(WM)/Lymphoplasmacytic lymphoma(LPL) Subjects will receive HMPL-523 with every 28-day
treatment cycle until disease progression, death, or intolerable toxicity, whichever comes
first.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05673460 -
A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)
|
Phase 1 |