A Phase I/II Dose Escalation and Expansion Study of BST-236 Plus Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Induction Chemotherapy
An open label multi centre study to assess the safety and efficacy of BST-236 in combination with venetoclax in adult patients unfit for standard therapy with newly diagnosed Acute Myeloid Leukemia (AML) Part 1 of the study will define the maximal tolerate dose of the combination treatment, while part 2 will expend the chosen dose, to assesses efficacy and safety of this combination. All patients will receive 2 induction courses with both BST-236 and venetoclax, responding patients will then be followed with up to 3 maintenance courses with BST-236 alone. Patients will be followed for 1 year in the study and additional 1 year in post study follow-up
• Adult ≥18 years of age
• Diagnosis of AML (de-novo AML or AML secondary to MDS or secondary to exposure to potentially leukemogenic therapies or agents)
• Not eligible for standard induction chemotherapy
• Peripheral white blood cell (WBC) count of \<25,000/μL
• Creatinine clearance ≥45 mL/min
• AST and/or aALT ≤2.5 X ULN)
• Total bilirubin ≤1.5 x ULN
• ECOG PS of:
⁃ 0 to 2 for patients ≥75 years of age
• Women of reproductive potential must have a negative serum pregnancy test within 48 hours of Study Day 1