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A Phase 1, Multi-center, Open-label, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
The primary objectives are to assess the safety and tolerability profile, determine the maximum tolerated dose (MTD), and/or the recommended Phase 2 dose (RP2D) of LP-108 administered daily as a single agent dosed orally in adult subjects with relapsed/refractory MDS/CMML/AML; to characterize the pharmacokinetics (PK) profile of LP-108 in adult subjects with relapsed/refractory MDS/CMML/AML.
Secondary objectives are to evaluate preliminary efficacy regarding the effect of LP-108 (monotherapy or combination therapy) on objective response rate (ORR) for AML (including rate of complete remission [CR]with or without minimal residual disease [MRD], CR with incomplete platelet recovery [CRp], CR with incomplete blood count recovery [CRi], morphologic leukemia-free state (MLFS), and partial remission [PR]), and ORR for MDS (CR with or without persistent dysplasia, PR, and marrow CR), and ORR for CMML (including CR, complete cytogenetic remission, PR, marrow response, and clinical benefit), progression-free survival (PFS), duration of response (DOR) (for all subjects achieving an objective response), event-free survival (EFS), and overall survival (OS) for AML, MDS and CMML.
Exploratory objectives are to explore blood borne biomarkers that may influence development of hematological malignancy and/or response to treatment (where response is defined broadly to include efficacy, tolerability, or safety); to study genes/genetic variation that may influence PK or response (ie, absorption, distribution, metabolism, excretion, safety, tolerability, and efficacy) to treatment, and/or genetic drivers of hematological malignancy such as AML, MDS, and CMML; to explore the relationship between PK and selected endpoints (ie, blood borne biomarkers), where deemed appropriate.
Once the MTD is declared and the RP2D is established, additional subjects will be enrolled in a cohort expansion phase (Phase 1b) that might adapt combination therapies with other agents such as hypomethylating agents (HMA), and in the United States and ex-US sites.
H. Lee Moffitt Cancer Center Research Institute
Not yet recruiting
Newave Pharmaceutical Inc
Published on BioPortfolio: 2019-10-30T14:03:46-0400
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