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Multicenter, open-label, phase I/II study of LB-208, a selective antagonist of the 5-hydroxytryptamine serotonin receptor 1B (HTR1B), in adults with relapsed or refractory (r/r) acute myeloid leukemia (AML) and high-risk (HR) relapsed or refractory (r/r) myelodysplastic syndrome (MDS).
THE OBJECTIVE OF THIS TRIAL, WHICH INVOLVES RESEARCH, IS TO EXAMINE THE SAFETY AND EFFICACY OF AN INVESTIGATIONAL DRUG CALLED LB-208. INVESTIGATIONAL MEANS THAT THE INVESTIGATIONAL DRUG TO BE TESTED IN THIS CLINICAL TRIAL HAS NOT BEEN AUTHORIZED BY NATIONAL DRUG REGULATORY AGENCIES, SUCH AS THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES.
Technical Summary
- MULTICENTER, OPEN-LABEL, PHASE I/II STUDY OF LB-208, A SELECTIVE ANTAGONIST OF THE 5-HYDROXYTRYPTAMINE SEROTONIN RECEPTOR 1B (HTR1B), IN ADULTS WITH RELAPSED OR REFRACTORY (R/R) ACUTE MYELOID LEUKEMIA (AML) AND HIGH-RISK (HR) RELAPSED OR REFRACTORY (R/R) MYELODYSPLASTIC SYNDROME (MDS).
- Code EudraCT: 2025-523396-38-00
- Protocol number: LB208-1-002
- Promoter: AOP Orphan pharmaceuticals
- Molecule/Drug: LB-208
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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