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

  • STATUS
    Recruiting
  • days left to enroll
    78
  • participants needed
    125
  • sponsor
    K36 Therapeutics, Inc.
Send
Updated on 24 November 2025
See if I qualify

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).

Description

This is a Phase I, open-label, dose-escalation and expansion study in adult patients with RRMM.

In the dose escalation phase (Part A), patients will be evaluated for DLTs during Cycle 1 (28 days). The KTX-1001 MTD, RP2D, and schedule will be determined.

In the dose expansion phase (Part B), patients with t(4;14) will receive KTX-1001 at the RP2D alone and in combination with investigational therapy Mezigdomide or SOC therapy (dexamethasone, carfilzomib or pomalidomide) to further define safety and tolerability and provide preliminary efficacy information.

Details
Condition Multiple Myeloma, Myeloma, Myeloma Multiple
Age 18years or above
Clinical Study IdentifierNCT05651932
SponsorK36 Therapeutics, Inc.
Last Modified on24 November 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

≥ 18 years of age
ECOG score ≤ 1
Multiple myeloma (as per IMWG)
≥ 3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody
Patients must be refractory to their last prior therapy
Cohorts A1/A2: Patients must have exhausted available therapeutic options that are expected to provide a meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance, or refusal of the therapy
t(4;14) confirmed by standard of care FISH testing
Measurable disease, including at least 1 of the following criteria
Serum M protein ≥ 0.50 g/dL (by SPEP)
Serum IgA ≥ 0.50 g/dL (IgA myeloma patients)
Urine M protein ≥ 200 mg/24 h (by UPEP)
sFLC involved light chain ≥ 10 mg/dL (100 mg/L) (patients with abnormal sFLC ratio)
Bone marrow plasma cells ≥ 30% (if only criterion for measurability)
Agreement to enroll into the REMS program (Cohort D- pomalidomide cohort only)

Exclusion Criteria

Treatment with the following therapies in the specified time period prior to first dose
Carfilzomib in the immediate last prior line of therapy for patients enrolled in Cohorts C1 and C2
Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D
Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
Cellular therapies ≤ 8 weeks
Autologous transplant < 100 days
Allogenic transplant ≤ 6 months, or > 6 months with active GVHD
Major surgery ≤ 4 weeks
Current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis
MM with extramedullary disease (applies to Cohorts A1 & A2: KTX-1001, C1 & C2: Carfilzomib, and D: Pomalidomide only)
Active CNS disease
Inadequate bone marrow function
Inadequate renal, hepatic, pulmonary, and cardiac function
Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocol
Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 14 days or 5 half-lives prior to first dose
Strong CYP1A2 inhibitors for patients receiving pomalidomide (Cohort D)
Active malignancy not related to myeloma requiring therapy within < 2 years prior to enrollment, or not in complete remission, with exceptions defined in protocol
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.