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A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Sponsor: K36 Therapeutics, Inc.
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2023-02-22
Completion Date
2028-06-30
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
Cohort A1 & A2: KTX-1001
KTX-1001: Orally for 28 days each cycle until progression. Dexamethasone: Orally once weekly
Cohort B1 & B2: KTX-1001+Mezigdomide
Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once weekly Drug: Mezigdomide Dexamethasone: Orally once weekly
Cohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®)
Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once weekly Drug: Carfilzomib (KYPROLIS®): IV, once weekly for 3 weeks in each 28-day cycle
Cohort D: KTX-1001+ pomalidomide (Pomalyst, Imnovid)
Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once a week Drug: Pomalidomide (Pomalyst, Imnovid): Orally, for 21 days in each 28-day cycle
Locations (22)
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
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
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
Atrium Health, Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 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
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, Spain
Hospital ClÃ-nic de Barcelona
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Instituto de Investigacion Biomedica de Salamanca (IBSAL)
Salamanca, Spain