RecruitingPhase 1NCT05651932

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

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


Sponsor

K36 Therapeutics, Inc.

Enrollment

125 participants

Start Date

Feb 22, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug that blocks an enzyme called MMSET — found at abnormally high levels in certain multiple myeloma patients — in people whose cancer has come back after many prior treatments. It is an early-phase dose-finding study. **You may be eligible if...** - You are 18 or older with multiple myeloma that has relapsed or is no longer responding to treatment - You have received at least 3 prior therapies including specific drug classes (a proteasome inhibitor, an IMiD, and an anti-CD38 antibody) - Your overall health is adequate (ECOG score 0–1) **You may NOT be eligible if...** - You have not previously tried the required treatment regimens - You have significant organ dysfunction or active infections - You have received certain prior experimental therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCohort A1 & A2: KTX-1001

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

DRUGCohort 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

DRUGCohort 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

DRUGCohort 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

View Full Details on ClinicalTrials.gov

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NCT05651932


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