Tests KTX-1001 alone and combined with other drugs in relapsed myeloma
Tests a new pill, KTX-1001, in adults with returning or resistant multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Key facts
- Where
- Edmonton and Toronto, CanadaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma that has come back or stopped responding to treatment, and who carry a specific gene change, t(4;14).
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Progressive multiple myeloma with measurable disease, that has come back or stopped responding to treatment. ECOG score of 1 or lower.
- Earlier treatment
- At least 1 and up to 3 earlier lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD) and an anti-CD38 antibody. The mezigdomide combination cohorts need at least 2 earlier lines.
- Biomarker or test result
- The t(4;14) gene change, confirmed by a FISH test on a fresh tumor biopsy.
Main reasons for not taking part
- Plasma cell leukemia, POEMS syndrome, light chain amyloidosis, myelodysplastic syndrome or a myeloproliferative neoplasm
- Active disease in the central nervous system (for the mezigdomide cohorts, known central nervous system myeloma)
- Active or uncontrolled infection
- Weak bone marrow, kidney, liver, lung or heart function
- Recent cancer treatment, surgery or transplant within the time limits set in the record
Read by machine on 9 November 2026.
Where in Canada
- Cross Cancer InstituteEdmonton, CanadaNot yet recruiting
- University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)Toronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- K36 Therapeutics, Inc.
- Trial code
- NCT05651932EU 2022-500801-41-00
- Record updated
- 22 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: ≥ 18 years of age; ECOG score ≤ 1; Multiple myeloma (as per IMWG); Prior therapy for MM: Participants must have received at least 1 and up to 3 prior lines of therapy as defined by IMWG, and the following drug classes: PI, IMiD, and anti-CD38 antibody. For mezigdomide combination Cohorts B1 and B2, participants must have received at least 2 prior lines of therapy; Participants must have a confirmed diagnosis of progressive MM (per IMWG), t(4;14) confirmed by fluorescence in situ hybridization (FISH) testing performed in a centralized Clinical Laboratory Improvement Amendments (CLIA) accredited laboratory via fresh tumor biopsy; 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: Treatment with the following therapies in the specified time period prior to first dose:; Patients in Cohorts B1 and B2 must not have received prior mezigdomide treatment; 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; Active CNS disease: participants with previously treated stable CNS disease are eligible, except for Cohorts B1 and B2 for which known CNS myeloma involvement is completely excluded; Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 7 days or 5 half-lives (whichever is longer) 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; 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; 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; Inadequate bone marrow function.