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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05153330
Other study ID # COVALENT-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 24, 2022
Est. completion date March 31, 2025

Study information

Verified date May 2024
Source Biomea Fusion Inc.
Contact Mona Vimal
Phone 1-844-245-0490
Email clinicaltrials@biomeafusion.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL.


Description:

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) with mixed lineage leukemia 1-rearranged (KMT2A/ MLL1r), nucleophosmin 1 (NPM1), diffuse large b-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic lymphoma (CLL)/ small lymphocytic lymphoma (SLL).


Recruitment information / eligibility

Status Recruiting
Enrollment 177
Est. completion date March 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years. - All subjects must have histologically or pathologically confirmed diagnosis of their malignancy and/ or measurable R/ R disease, as follows: 1. Cohort 1 only: Refractory or relapsed acute leukemia defined as > 5% blasts in the bone marrow or reappearance of blasts in the peripheral blood. 2. Cohort 2 only: Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously indolent lymphoma (e.g., follicular lymphoma) with documented clinical or radiological evidence of progressive or persistent disease. At study entry, subjects must have measurable disease as per the revised criteria for response assessment of lymphoma. 3. Cohort 3 only: Measurable MM. 4. Cohort 4 only: Previously treated subjects with active CLL/SLL with meeting at least 1 of the iwCLL 2018 criteria for requiring treatment. - Subjects must be refractory or must have progressed on, or following discontinuation of the most recent anti-cancer therapy, with the following considerations: 1. Cohort 1 only: Have failed or are ineligible for any approved standard of care therapies, including HSCT (Hematopoietic Stem Cell Transplantation). 2. Cohort 2 only: Must have received at least 2 previous systemic regimens for the treatment of their de novo or transformed DLBCL. 3. Cohort 3 only: Must have received at least 3 anti-MM regimens including proteasome inhibitor. 4. Cohort 4 only: Must have received at least 2 prior systemic treatment regimens. - ECOG performance status of 0-2 and an estimated expected life expectancy of > 3 months in the opinion of the Investigator. - Adequate organ function. - Both men and women of childbearing potential or their partners must use adequate birth control measures during the course of the trial and for at least 90 days after discontinuing study treatment. Exclusion Criteria: Subjects who meet any of the following criteria will not be enrolled in the study (all cohorts, unless otherwise indicated): - Certain disease subtypes or occurrences, as follows: 1. Cohort 1: Acute promyelocytic leukemia (APL), chronic myeloid leukemia (CML) in blast crisis. 2. Cohort 2: Primary mediastinal B-cell lymphoma (PMBCL), DLBCL transformed from diseases other than indolent non-Hodgkin's Lymphoma (NHL). 3. Cohort 3: Active plasma cell leukemia, myeloma with amyloidosis, systemic light chain amyloidosis. 4. Cohort 4: Known or suspected history of Richter's transformation. - White Blood Count (WBC) > 50,000/µL (uncontrollable with cytoreductive therapy) (Cohort 1 only). - Known central nervous involvement, as follows: 1. Cohort 1: Clinically active central nervous system (CNS) leukemia. Previously controlled CNS leukemia is acceptable. 2. Cohort 2: Active CNS lymphoma or meningeal involvement. 3. Cohort 3: Active CNS MM. 4. Cohort 4: Active CNS leukemia. - Prior menin inhibitor therapy. - Known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen. - Subjects with a pre-existing disorder predisposing them to a serious or life-threatening infection. - An active uncontrolled acute or chronic systemic fungal, bacterial, or viral infection.

Study Design


Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Cancer
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B Cell Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Myeloma, Plasma-Cell
  • Myelomatosis
  • Neoplasms, Plasma Cell
  • Plasma Cell Myeloma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Progression
  • Refractory
  • Small Lymphocytic Lymphoma

Intervention

Drug:
BMF-219
BMF-219 is orally administered in continuous 28 day cycles. Alternative BID dosage may be used.

Locations

Country Name City State
Greece Alexandra General Hospital of Athens Athens
Greece Evangelismos General Hospital of Athens Athens
Italy AOU Ospedali Riuniti Ancona Ancona
Italy ASST Papa Giovanni XXIII Hospital Bergamo Bergamo
Italy Instituto Clinico Humanitas Milan
Italy IRCCS Ospedale San Raffaele, Programma di Ricerca Strategica su LLC Milan
Italy Istituto Europeo di Oncologia Milano
Italy Ospedale Santa Maria della Misericordia Perugia
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma
Netherlands Amsterdam UMC Amsterdam
Netherlands UMCG Groningen Groningen
Netherlands Radboud University Medical Center Nijmegen
Netherlands Erasmus University Medical Center Rotterdam Rotterdam
Spain Hospital General de Albacete Albacete
Spain Hospital Clinic de Barcelona Barcelona
Spain Institut Catala d'Oncologia Barcelona
Spain Hospital San Pedro de Alcántara Cáceres
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario de la Princesa Madrid
Spain Hospital Universitario Fundación Jiménez Díaz Madrid
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Universitario y Politécnico La Fe Valencia
United States Blood & Marrow Transplant Group of GA (Northside Hospital) Atlanta Georgia
United States Northwestern University Chicago Illinois
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Henry Ford Hospital Detroit Michigan
United States Virginia Cancer Specialists Gainesville Virginia
United States MD Anderson Cancer Center Houston Texas
United States University of California, Irvine Irvine California
United States Mayo Clinic Jacksonville Florida
United States UCLA Department of Medicine Los Angeles California
United States University of Southern California Norris Cancer Center Los Angeles California
United States Mount Sinai Medical Center Miami Beach Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States UC Davis Comprehensive Cancer Center Sacramento California
United States Stanford Cancer Center Stanford California
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Biomea Fusion Inc.

Countries where clinical trial is conducted

United States,  Greece,  Italy,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine Optimal Biologic Dose (OBD) and RP2D of BMF-219 monotherapy for (Cohorts 1, 2, 3 & 4) Determine Optimal Biologic Dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy in subjects with refractory or relapsed (R/ R) acute leukemia (Cohort 1), diffuse large B-cell lymphoma (Cohort 2), multiple myeloma (Cohort 3), and chronic lymphocytic leukemia/ small lymphocytic lymphoma (Cohort 4). At the end of Cycle 1 (each Cycle is 28 Days in duration)
Secondary Evaluate the Safety treatment-emergent TEAEs and SAEs Evaluate the Safety of BMF-219 as expressed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). At the end of Cycle 1 (each Cycle is 28 Days in duration)
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