A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

Who is this study for? Patients with Leukemia
What treatments are being studied? JNJ-75276617
Status: Recruiting
Location: See all (99) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

⁃ Phase 1:

• Age 2 years and above (pediatric cohort only), all other cohorts 18 years and above

• Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options

• 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 (\<=) 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate greater than equal (\>=) 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>50 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula

• Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric 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 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

Locations
United States
California
City of Hope
RECRUITING
Duarte
University of California Irvine Medical Center
COMPLETED
Orange
University of California San Francisco
RECRUITING
San Francisco
University of California San Francisco
RECRUITING
San Francisco
Illinois
University of Chicago
RECRUITING
Chicago
Indiana
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
RECRUITING
Indianapolis
Kentucky
Norton Cancer Institute
COMPLETED
Louisville
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Start Midwest
RECRUITING
Grand Rapids
New Mexico
University of New Mexico
RECRUITING
Albuquerque
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
NYU Langone Medical Center
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Oregon
Oregon Health And Science University
RECRUITING
Portland
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Rhode Island
Maine Health
RECRUITING
Providence
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Texas
Baylor University Medical Center
RECRUITING
Dallas
Houston Methodist Hospital
RECRUITING
Houston
MD Anderson
RECRUITING
Houston
San Antonio Methodist TX Transplant Physicians Group
RECRUITING
San Antonio
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Wisconsin
Medical College of WI at Froedtert
RECRUITING
Milwaukee
Other Locations
Australia
Monash Medical Centre
RECRUITING
Clayton
Royal Perth Hospital
RECRUITING
Perth
Gold Coast University Hospital
RECRUITING
Southport
Brazil
Instituto D Or de Pesquisa e Ensino
RECRUITING
Brasília
Liga Norte Riograndense Contra O Cancer
RECRUITING
Natal
Ministerio da Saude Instituto Nacional do Cancer
RECRUITING
Rio De Janeiro
Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
São Paulo
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
RECRUITING
São Paulo
Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
São Paulo
Canada
Hopital Maisonneuve Rosemont
RECRUITING
Montreal
Princess Margaret Cancer Centre University Health Network
RECRUITING
Toronto
Vancouver Coastal Health
RECRUITING
Vancouver
China
Peking University First Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
West China Hospital Si Chuan University
RECRUITING
Chengdu
Nanfang Hospital of Southern Medical Hospital
RECRUITING
Guangzhou
First Affiliated Hospital Medical School of Zhejiang University
RECRUITING
Hangzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First Affiliated Hospital of NanChang University
RECRUITING
Nanchang
Zhongda Hospital Southeast University
RECRUITING
Nanjing
Institute of Hematology and Blood Diseases Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Henan Cancer Hospital
RECRUITING
Zhengzhou
France
Hopital Jean Minjoz
RECRUITING
Besançon
Institut Paoli Calmettes
RECRUITING
Marseille
CHU de Nantes hotel Dieu
RECRUITING
Nantes
Hopital Saint Louis
RECRUITING
Paris
Hopital trousseau- APHP
RECRUITING
Paris
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
COMPLETED
Pessac
CHU Lyon Sud
RECRUITING
Pierre-bénite
Institut de Cancerologie Strasbourg Europe ICANS
RECRUITING
Strasbourg
Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
Toulouse
CHU Bretonneau
RECRUITING
Tours
CHRU Nancy Brabois
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy
RECRUITING
Villejuif
Israel
Carmel Medical Center
RECRUITING
Haifa
Hadassah University Hospita Ein Kerem
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Japan
Kyushu University Hospital
RECRUITING
Fukuoka
Fukushima Medical University Hospital
RECRUITING
Fukushima
Kanazawa University Hospital
RECRUITING
Kanazawa
National Cancer Center Hospital East
RECRUITING
Kashiwa
Kobe City Medical Center General Hospital
RECRUITING
Kobe
Gunmaken Saiseikai Maebashi Hospital
RECRUITING
Maebashi
Nagoya University Hospital
RECRUITING
Nagoya
Hokkaido University Hospital
RECRUITING
Sapporo
NTT Medical Center Tokyo
RECRUITING
Tokyo
Yamagata University Hospital
RECRUITING
Yamagata
University of Fukui Hospital
RECRUITING
Yoshida
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Spain
Hosp Clinic de Barcelona
RECRUITING
Barcelona
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp Univ Fund Jimenez Diaz
RECRUITING
Madrid
Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Madrid
Clinica Univ. de Navarra
RECRUITING
Pamplona
Hosp Clinico Univ de Salamanca
RECRUITING
Salamanca
Hosp. Virgen Del Rocio
RECRUITING
Seville
Hosp. Clinico Univ. de Valencia
RECRUITING
Valencia
Taiwan
China Medical University Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
United Kingdom
University Hospital of Wales
RECRUITING
Cardiff
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
The Clatterbridge Cancer Centre
RECRUITING
Liverpool
Guys and St Thomas NHS Foundation Trust
RECRUITING
London
University College London Hospitals
RECRUITING
London
The Christie Nhs Foundation Trust
RECRUITING
Manchester
Oxford University Hospitals NHS Trust
RECRUITING
Oxfordshire
University Hospitals Plymouth NHS Trust
RECRUITING
Plymouth
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2021-05-19
Estimated Completion Date: 2028-05-26
Participants
Target number of participants: 400
Treatments
Experimental: Bleximenib
Participants in Phase 1 Part 1 (dose escalation) will receive bleximenib orally. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Doses (RP2Ds) have been identified. Participants in Phase 1 Part 2 (dose expansion) will receive bleximenib orally at the RP2D(s) determined in Part 1. In Phase 2 participants will receive bleximenib at the RP2D to evaluate anti-leukemia activity and demonstrate acceptable safety at the RP2D(s).
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov