Multiple Myeloma Clinical Trial
Official title:
A Phase 1/1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of LP-118 in Subjects With Relapsed or Refractory Hematological Malignancies
This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 subjects.
Primary objectives of the study are to assess the safety and tolerability profile, determine the maximum tolerated dose (MTD), and/or the recommended Phase 2 dose (RP2D) of LP-118 administered once daily (QD) as a single agent dosed orally in adult subjects with relapsed/refractory (low risk tumor lysis) CLL/SLL (Group 1a); relapsed/refractory MF, CMML-2, MDS/MPN, MDS-BP, MDS; AML with WBC ≤ 25 × 10^9 cells/L (Group 1b); relapsed/refractory NHL, RT, MM, T-PLL (Group 1c); relapsed/refractory ALL (Group 1d); relapsed/refractory (intermediate and high tumor lysis risk) CLL/SLL, NHL, RT, T-PLL (Group 2); Secondary objectives of the study are to evaluate preliminary efficacy regarding the effect of LP-118 on objective response rate (ORR) using disease specific response criteria, progression-free survival (PFS), and duration of response (DOR), and overall survival (OS) in adult subjects with relapsed/refractory (low risk tumor lysis) CLL/SLL (Group 1a); relapsed/refractory MF, CMML-2, MDS/MPN, MDS-BP, MDS; AML with WBC ≤ 25 × 10^9 cells/L (Group 1b); relapsed/refractory NHL, RT, MM, T-PLL (Group 1c); relapsed/refractory ALL (Group 1d); relapsed/refractory (intermediate and high tumor lysis risk) CLL/SLL, NHL, RT, T-PLL (Group 2); ;
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