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Brief Title: A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Official Title: A Phase 1 Study of KTX-1001, an Oral, First-In-Class, Selective, and Potent MMSET Catalytic Inhibitor That Suppresses H3K36me2 in Patients With Relapsed and Refractory Multiple Myeloma
Study ID: NCT05651932
Brief 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 translocation t(4;14) or a GOF mutation in MMSET (eg, E1099K) will be enrolled. Patients will receive KTX-1001 at the RP2D to further define safety and tolerability and provide preliminary efficacy information.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Hospital - Phoenix, Phoenix, Arizona, United States
UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic, San Francisco, California, United States
Mayo Clinic Hospital - Florida, Jacksonville, Florida, United States
The Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
University of Kansas Cancer Center - Fairway, Westwood, Kansas, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic - Transplant Center - Rochester, Rochester, Minnesota, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke University Hospital, Durham, North Carolina, United States
Tennessee Oncology, Nashville, Tennessee, United States
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas, United States
University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital), Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu, Nantes, , France
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, , France
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital ClÃ-nic de Barcelona, Barcelona, , Spain
Instituto de Investigacion Biomedica de Salamanca (IBSAL), Salamanca, , Spain