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Brief Title: A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
Official Title: A Phase I/Ib Study of BP1002 (a Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
Study ID: NCT05190471
Brief Summary: This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory/relapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemic effects of BP1002 as single agent (dose escalation phase) followed by assessing BP1002 in combination with decitabine (dose expansion phase).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Scripps Green Hospital, La Jolla, California, United States
UCLA Medical Center, Los Angeles, California, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital, New York, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
Name: Gail J Roboz, MD
Affiliation: Weill Cornell Medical College - New York-Presbyterian Hospital
Role: PRINCIPAL_INVESTIGATOR