Groupe d'Etude en Oncologie du Quebec

Title	Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Protocole ID	CA235-0001
ClinicalTrials.gov ID	NCT06419634
Cancer Type(s)	Myelodysplastic Syndrome
Phase	Phase I
Stage	Relapse/refractory (2nd line and more)
Study Type	Clinical
Drug	BMS-986497 (ORM-6151)
Institution	CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS 3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
City
Principal Investigator	Dr. Sarit Assouline
Coordinator	Fabio Ferraira 514-340-8222 poste 24624
Status	Recruiting
Activation Date
Eligibility Criteria	Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Detectable levels of cluster of differentiation 33 (CD33) expression. Failed alternative therapies with established benefit. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.
Exclusion Criteria	Acute Promyelocytic Leukemia. Clinically active central nervous system leukemia. Active malignant solid tumor. Pregnant or breastfeeding. Other protocol-defined inclusion/exclusion criteria apply.

Groupe d'étude en oncologie du Québec