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RECRUITING
NCT05651932
PHASE1

A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma

Sponsor: K36 Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Cohort A1 & A2: KTX-1001

KTX-1001: Orally for 28 days each cycle until progression. Dexamethasone: Orally once weekly

DRUG

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

DRUG

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

DRUG

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