7009Background: Isocitrate dehydrogenase 1 mutations (IDH1m) occur in 7-14% of AML patients (pts) and 3% of MDS pts. FT-2102 is a highly potent, selective small molecule inhibitor of IDH1m without anticipated CYP or QTc liabilities at the recommended phase 2 dose. Methods: A Phase 1/2 study was initiated to evaluate the safety, PK/PD, and clinical activity of FT-2102 alone or in combination with azacitidine (AZA) or cytarabine in IDH1m AML/MDS pts. Safety for all pts and efficacy for evaluable pts are reported. Results: At the data cutoff, 35 pts with a median of 2 prior regimens (range 1-9) had received FT-2102 in dose-escalation, including 22 single-agent (SA) and 13 AZA combination (CO) pts. Sixteen pts remain on treatment (SA, n = 10; CO, n = 6) with a median of 2 treatment cycles (range 1-16); 4 pts discontinued for transplant. FT-2102 has been well tolerated both as SA and in combination with AZA. Overall, regardless of causality, most treatment emergent AEs (TEAEs) were grade (gr) 1/2; most common ...