Multicentre, open-label, phase 1/2 study of LB-208, selective antagonist of the serotonin 5-hydroxytryptamine receptor 1B (HTR1B), in adults with relapse or refractory (r/r) acute myeloid leukaemia (AML) and r/r higher-risk (HR) myelodysplastic syndrome (MDS)

Trial status: Authorised Plasma concentration-time profiles, and PK parameters of LB-208., Response according to the revised European LeukemiaNet (ELN) Response Criteria in AML (Döhner et al., 2022) and revised International Working Group 2023 (IWG 2023) in HR-MDS (Zeidan, Platzbecker, et al., 2023). Response for all patients will be assessed by the site Investigators. Safety, and toxicity will be described by observed frequency and severity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0., including dose limiting toxicity (DLT) rate, adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation.

Plasma concentration-time profiles, and PK parameters of LB-208., Response according to the revised European LeukemiaNet (ELN) Response Criteria in AML (Döhner et al., 2022) and revised International Working Group 2023 (IWG 2023) in HR-MDS (Zeidan, Platzbecker, et al., 2023). Response for all patients will be assessed by the site Investigators.

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 60 participants