Actively Recruiting
A Phase 1 Study of KTX-1001, an Oral, Selective MMSET Inhibitor, in Patients With Relapsed and Refractory Multiple Myeloma
Led by K36 Therapeutics, Inc. · Updated on 2026-06-08
165
Participants Needed
22
Research Sites
26 weeks
Total Duration
On this page
Sponsors
K
K36 Therapeutics, Inc.
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of KTX-1001, a new oral drug that selectively inhibits the MMSET enzyme involved in multiple myeloma, in adults with relapsed or refractory multiple myeloma (RRMM). This Phase I study aims to find the best dose and understand how the drug works alone and combined with other therapies in patients with a specific genetic change called t(4;14). The study has two parts: a dose escalation phase where different doses of KTX-1001 are tested over 28-day cycles to find the recommended dose and maximum tolerated dose; and a dose expansion phase where patients receive KTX-1001 alone or combined with Mezigdomide, dexamethasone, carfilzomib, or pomalidomide. Treatments are given orally or by infusion depending on the combination, with dexamethasone taken once weekly. Participants will be monitored for response to treatment, drug safety, and how their bodies process the drug through regular assessments during the study. The main outcomes include determining the recommended dose and initial effectiveness of KTX-1001 combinations. The study is expected to continue until June 2028, with ongoing evaluations throughout treatment cycles.
CONDITIONS
Brief Title
A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- ECOG performance status of 0 or 1
- Diagnosed with multiple myeloma according to IMWG criteria
- Received at least 1 and up to 3 prior lines of therapy including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies
- For Mezigdomide combination cohorts, received at least 2 prior lines of therapy
- Confirmed progressive multiple myeloma with t(4;14) genetic change by FISH testing
- Measurable disease defined by specific protein levels in serum or urine or bone marrow plasma cells
- Agreement to enroll in REMS program for pomalidomide cohort
You will not qualify if you...
- Prior treatment with mezigdomide for cohorts B1 and B2
- Prior carfilzomib in immediate last line of therapy for cohorts C1 and C2
- Prior pomalidomide in immediate last line of therapy for cohort D
- Radiation, chemotherapy, immunotherapy, or other anticancer therapy within 2 weeks before first dose
- Cellular therapies within 8 weeks before first dose
- Autologous transplant less than 100 days before first dose
- Allogenic transplant less than 6 months before first dose or with active GVHD
- Major surgery within 4 weeks before first dose
- Current plasma cell leukemia, POEMS syndrome, solitary bone lesions only, myelodysplastic syndrome, myeloproliferative neoplasm, or light chain amyloidosis
- Active central nervous system disease (except stable treated cases, excluded in cohorts B1 and B2)
- Inadequate bone marrow, kidney, liver, lung, or heart function
- Active, ongoing, or uncontrolled infections
- Use of acid reducing agents or strong CYP3A4 inhibitors or inducers within 7 days before first dose
- Use of strong CYP1A2 inhibitors for cohort D
- Active malignancy unrelated to myeloma requiring therapy within 2 years or not in remission with exceptions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive KTX-1001 orally for 28 days each cycle until disease progression. Depending on cohort, treatment may include dexamethasone once weekly, and/or Mezigdomide, carfilzomib (IV once weekly for 3 weeks each cycle), or pomalidomide for 21 days each cycle.
Visits weekly for dosing and assessments during each 28-day cycle
Trial Site Locations
Total: 22 locations
1
UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic
San Francisco, California, United States, 94143
Actively Recruiting
2
Mayo Clinic Hospital - Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
The Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Mayo Clinic - Transplant Center - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Atrium Health, Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
10
Duke University Hospital
Durham, North Carolina, United States, 27705
Actively Recruiting
11
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
13
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75235
Actively Recruiting
14
University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
15
Universitaire de Lille
Villeneuve-d'Ascq, France, France
Actively Recruiting
16
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, France
Actively Recruiting
17
Centre Hospitalier Universitaire de Poitiers (CHU de Poitiers)
Poitiers, France
Actively Recruiting
18
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
Actively Recruiting
19
Clínica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
20
Hospital ClÃ-nic de Barcelona
Barcelona, Spain
Actively Recruiting
21
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
22
Instituto de Investigacion Biomedica de Salamanca (IBSAL)
Salamanca, Spain
Actively Recruiting
Research Team
S
Soo Bang, MHSA
R
Raymond Burgos, BSBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here