a phase 1/2 study of bleximenib in participants with acute leukemia

Conditions: Acute Leukemias; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to determine the recommended phase 2 dose(s) (rp2d\[s\]) of bleximenib in phase 1 (part 1 \[dose escalation\] and to determine the safety and tolerability at rp2d in phase 1 part 2 (dose expansion). the purpose of the phase 2 part of the study is to evaluate the efficacy of bleximenib at the rp2d.


Eligibility criteria:
inclusion criteria: phase 1: * relapsed or refractory (r/r) acute leukemia and has exhausted, or is ineligible for, available therapeutic options * participants greater than or equal (\>=)12 and less than (\<) 18 years of age are only eligible for the phase 1 adolescent cohort * acute leukemia harboring histone-lysine n-methyltransferase 2a (kmt2a), nucleophosmin 1 gene (npm1) or nucleoporin 98 gene or nucleoporin 214 gene (nup98 or nup214) alterations phase: 2 * participants greater than 18 years are eligible * must have had an initial diagnosis of acute myeloid leukemia (aml) per the who 2022 classification criteria and have relapsed/refractory disease * aml harboring kmt2a-r (gene rearrangement/translocation) or npm1 mutations only for both phase 1 and 2: * pretreatment clinical laboratory values meeting the following criteria: (a) hematology: white blood cell (wbc) count less than or equal to (\ =) 50 milliliter per minute (ml/min) per four variable modified diet in renal disease (mdrd) equation * eastern cooperative oncology group (ecog) performance status grade of 0, 1 or 2. adolescent participants only: performance status \>=70 by lansky scale (for participants less than \[\ =70 karnofsky scale (for participants \>=16 years of age) * a female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment * participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment exclusion criteria: * acute promyelocytic leukemia, diagnosis of down syndrome associated leukemia or juvenile myelomonocytic leukemia according to world health organization (who) 2016 criteria * active central nervous system (cns) disease * prior solid organ transplantation * qtc according to fridericia's formula (qtcf) for males \>= 450 millisecond (msec) or for females \>= 470 msec. participants with a family history of long qt syndrome are excluded * exclusion criteria related to stem cell transplant: a. received prior treatment with allogenic bone marrow or stem cell transplant \<=3 months before the first dose of study treatment; b. has evidence of graft versus host disease; c. received donor lymphocyte infusion \<=1 month before the first dose of study treatment; d. requires immunosuppressant therapy (exception: daily doses \<=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement) * prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)