A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Start Date
2/22/2023
Completion Date
6/30/2028
Summary
A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM).
Detailed Description
This is a Phase I, open-label, dose-escalation and expansion study in adult patients with RRMM. In the dose escalation phase (Part A), patients will be evaluated for DLTs during Cycle 1 (28 days). The KTX-1001 MTD, RP2D, and schedule will be determined. In the dose expansion phase (Part B), patients with t(4;14) will receive KTX-1001 at the RP2D alone and in combination with investigational therapy Mezigdomide or SOC therapy (dexamethasone, carfilzomib or pomalidomide) to further define safety and tolerability and provide preliminary efficacy information.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Cohort A1 & A2: KTX-1001
Cohort B1 & B2: KTX-1001+Mezigdomide
Cohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®)
Cohort D: KTX-1001+ pomalidomide (Pomalyst, Imnovid)
Conditions
Locations
UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic
San Francisco, California 94143
United States
Mayo Clinic Hospital - Florida
Jacksonville, Florida 32224
United States
The Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Mayo Clinic - Transplant Center - Rochester
Rochester, Minnesota 55905
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
Atrium Health, Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Duke University Hospital
Durham, North Carolina 27705
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas 75235
United States
University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)
Toronto, Ontario M5G 2C4
Canada
Universitaire de Lille
Villeneuve-d'Ascq, France
France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes,
France
Centre Hospitalier Universitaire de Poitiers (CHU de Poitiers)
Poitiers,
France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse,
France
Clínica Universidad de Navarra
Pamplona, Navarre 31008
Spain
Hospital ClÃ-nic de Barcelona
Barcelona,
Spain
Hospital Universitario 12 de Octubre
Madrid,
Spain
Instituto de Investigacion Biomedica de Salamanca (IBSAL)
Salamanca,
Spain