M.D. Anderson Cancer Center
The goal of this clinical research study is to find the highest tolerable dose of PLM-102 that can be given to patients who have AML/MDS that is refractory and/or relapsed. The safety of PLM-102 will also be studied.
Primary Objective: To study the safety and tolerability of PLM-102 in terms of treatment emergent adverse events (TEAE) and dose limiting toxicities (DLT). To establish the RP2D of PLM-102 based on the totality of the data. Secondary Objectives: To estimate rate of CR/CRh by 4 cycles of treatment To estimate overall response rate (ORR=CR/CRh/CRi/MLFS/PR) by 4 cycles of treatment To determine duration of response (DOR) of CR/CRh To determine overall survival (OS) Exploratory Objectives: To characterize the pharmacokinetics (PK) of PLM-102 and its metabolite(s) To characterize pharmacodynam…
Inclusion Criteria: Patients need to be adults with R/R AML or MDS/AML per the ICC 2022 or the WHO 2022.4,5 1. Relapsed or refractory disease following standard treatment: 1. Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR/CRi/MLFS 2. Refractory: Failure to achieve CR/CRi/MLFS following initial treatment, with evidence of persistent leukemia by blood and/or bone marrow evaluation with blasts ≥5% 2. ECOG PS 0 to 2 3. Patients with actionable mutations with available FDA-approved therapies, e.g.,…
Given by mouth
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