A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia

Last Updated September 4, 2024

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CR108998

OVERVIEW

Sexes Eligible for Study
all
Age
12+ years
Phase
phase 1

1
Sites
26 Sites
Status

Recruiting

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.

CONDITIONS

Acute Leukemias
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia

ELIGIBILITY

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 with a body weight of >= 40 kg 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.
* 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 (<=) 20*10^9/liter (L) and renal function; Estimated or measured glomerular filtration rate greater 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 [<]16 years of age) or >=70 Karnofsky scale (for participants >=16 years of age)
* A participant 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
* A participant must agree to all the following during the study and for 90 days after the last dose of study treatment: (a) wear a condom when engaging in any activity that allows for passage of ejaculate to another person; (b) not to donate sperm or freeze for future use for the purpose of reproduction. In addition, the participant should be advised of the benefit for a partner to use a highly effective method of contraception as condom may break or leak

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)

Inclusion Criteria:

Phase 1:

More...

DETAILS

LOCATIONS

Locations in:

United States, Australia, France, Spain, United Kingdom

Country (5)	City or Province (26)	Status
United States	Duarte City of Hope	RECRUITING
United States	Orange University of California Irvine Medical Center	COMPLETED
United States	San Francisco University of California San Francisco	RECRUITING
United States	Louisville Norton Cancer Institute	COMPLETED
United States	Boston Massachusetts General Hospital	RECRUITING
United States	Boston Dana Farber Cancer Institute	RECRUITING
United States	New York NYU Langone Medical Center	RECRUITING
United States	Houston MD Anderson	RECRUITING
United States	Milwaukee Medical College of WI at Froedtert	RECRUITING
Australia	Clayton Monash Medical Centre	RECRUITING
Australia	Perth Royal Perth Hospital	RECRUITING
Australia	Southport Gold Coast University Hospital	RECRUITING
France	Marseille Institut Paoli Calmettes	RECRUITING
France	Nantes Cedex 1 CHU de Nantes hotel Dieu	RECRUITING
France	Paris Hopital trousseau- APHP	RECRUITING
France	Pessac Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie	COMPLETED
France	Toulouse Institut Universitaire du Cancer Toulouse Oncopole	RECRUITING
France	Tours cedex CHU Bretonneau	RECRUITING
Spain	Barcelona Hosp Clinic de Barcelona	RECRUITING
Spain	Madrid Hosp Univ Fund Jimenez Diaz	RECRUITING
Spain	Pamplona Clinica Univ. de Navarra	RECRUITING
United Kingdom	London Guy's and St Thomas' NHS Foundation Trust	RECRUITING
United Kingdom	Manchester The Christie Nhs Foundation Trust	RECRUITING
United Kingdom	Oxfordshire Oxford University Hospitals NHS Trust	RECRUITING
United States	Grand Rapids Start Midwest	RECRUITING
Spain	Barcelona Hosp Univ Vall D Hebron	RECRUITING

Geo Locations

34.13945, -117.97729

33.78779, -117.85311

37.77493, -122.41942

38.25424, -85.75941

42.35843, -71.05977

40.71427, -74.00597

29.76328, -95.36327

43.0389, -87.90647

-37.91667, 145.11667

-31.95224, 115.8614

-27.96724, 153.39796

43.29551, 5.38958

47.21725, -1.55336

48.85341, 2.3488

44.81011, -0.64129

43.60426, 1.44367

47.38333, 0.68333

41.38879, 2.15899

40.4165, -3.70256

42.81687, -1.64323

51.50853, -0.12574

53.48095, -2.23743

51.750337, -1.2146896

42.96336, -85.66809

41.38879, 2.15899

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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