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Spots Global Cancer Trial Database for A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma

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Trial Identification

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

Interventions

KTX-1001

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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