Phase 1 PLM-102 FLT3 inhibitor (next-generation tyrosine kinase inhibitor) in R/R AML/MDS

This Phase 1, open-label, dose-escalation study at MD Anderson Cancer Center is designed to define the maximum tolerated dose and recommended Phase 2 dose of PLM-102, an oral small-molecule FLT3 tyrosine kinase inhibitor being tested as monotherapy in relapsed or refractory AML, including AML evolving from MDS/CMML (“MDS/AML”) after prior standard therapies. The primary focus is safety (treatment-emergent adverse events and dose-limiting toxicities), with early efficacy readouts such as composite complete remission rates and overall response by 4 cycles, plus pharmacokinetics/pharmacodynamics. The scientifically interesting angle is the “next-generation” FLT3 program rationale: resistance to approved FLT3 inhibitors is common, and preclinical work presented in the hematology community positions PLM-102 as potentially active against FLT3 inhibitor–resistance settings. In this population today, care is heterogeneous and commonly includes salvage chemotherapy, venetoclax-based regimens, mutation-directed agents when present (FLT3, IDH1/2, menin), and allogeneic transplant when feasible; this trial explores whether a newer FLT3-targeted agent can provide another oral option after those pathways are exhausted.