A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Primary outcome measure(s)
- Dose Escalation: Determination of Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose (MTD) Dose Expansion: Provide preliminary efficacy data on the antitumor effects of KTX-1001 in combination with other anti-myeloma therapy — Cycle 1 (28 days)
Incidence of dose-limiting toxicity (DLTs), treatment-emergent adverse events (TEAEs), treatment-related AEs, and clinically significant changes in laboratory test results
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic | San Francisco | California | Recruiting |
| Mayo Clinic Hospital - Florida | Jacksonville | Florida | Recruiting |
| University of Miami Don Soffer Clinical Research Center | Miami | Florida | Not Yet Recruiting |
| The Winship Cancer Institute of Emory University | Atlanta | Georgia | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Not Yet Recruiting |
| Mayo Clinic - Transplant Center - Rochester | Rochester | Minnesota | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Memorial Sloan-Kettering Cancer Center | New York | New York | Recruiting |
| Atrium Health, Levine Cancer Institute | Charlotte | North Carolina | Recruiting |
| Duke University Hospital | Durham | North Carolina | Recruiting |
| Cleveland Clinic - Taussig Cancer Institute | Cleveland | Ohio | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Medical University of South Carolina (MUSC) - Hollings Cancer Center | Charleston | South Carolina | Recruiting |
| Tennessee Oncology | Nashville | Tennessee | Recruiting |
| University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center | Dallas | Texas | Recruiting |
| Oncology Consultants | Houston | Texas | Recruiting |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | Recruiting |
| Cross Cancer Institute | Edmonton | Alberta | Not Yet Recruiting |
| University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital) | Toronto | Ontario | Recruiting |
| Universitaire de Lille | Villeneuve-d'Ascq | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers (CHU de Poitiers) | Poitiers | France | Recruiting |
| Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse | France | Recruiting |
| Clínica Universidad de Navarra | Pamplona | Navarre | Recruiting |
| Hospital ClÃ-nic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Instituto de Investigacion Biomedica de Salamanca (IBSAL) | Salamanca | Spain | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05651932 on ClinicalTrials.gov ↗ ← All trials in France