Trial intelligence / Profile preview

PXS-5505 plus azacitidine in MDS and CMML

DRKS00028761Phase 2Recruiting

Sponsor
Heidelberg University
Start
May 2025
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules
Countries
1
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Overview

Phase 2, open-label trial of amsulostat and azacitidine in myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) (2 arms), sponsored by Heidelberg University. Primary endpoints: Determine the recommended Phase II dose (RP2D) of PXS-5505 in combination with azacitidine based on maximum tolerated dose (MTD) assessment (Phase I) and Safety profile of PXS-5505 in combination with azacitidine (Phase II). Started May 2025; status: recruiting.

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Drugs

amsulostatazacitidine
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Conditions

myelodysplastic syndrome (MDS)chronic myelomonocytic leukemia (CMML)

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