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)

Condition studied

Relapse or refractory (r/r) acute myeloid leukaemia (AML) and r/r higher-risk (HR) myelodysplastic syndrome (MDS)

Investigational medicinal product(s)

Eligibility

Primary endpoint

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.

Endpoint detail

Plasma concentration-time profiles, and PK parameters of LB-208.