Stopped: Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.
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Escalation Part: Incidence of dose-limiting toxicity (DLT)
Timeframe: Day 1 to Day 28
Japan Cohort C: Incidence of DLT in Japanese participants
Timeframe: Day 1 to Day 28
Expansion/Optimization part (Cohorts A1, A2 & D), AML: Proportion of participants who have a CR + CRh + CRi according to the modified AML IWG 2003 criteria
Timeframe: Up to 6 months
Expansion/Optimization part (Cohort B), MDS: Overall response rate (CR + CR equivalent + PR + CRL + CRh + HI) according to the IWG 2023 MDS response criteria
Timeframe: Up to 6 months