> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-an-mmset-inhibitor-in-patients-with-relapsed-and-e941247a-c4a5-45cc-922a-23e060447e45 > Record changed: 2026-10-13 # A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma NCT05651932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) Participants 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) Lead sponsor K36 Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) Start date 2023-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) Number of sites 26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Short title** A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Dates **Completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **First posted** 2022-12-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Registry last updated** 2026-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Primary completion date** 2027-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Start date** 2023-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Size and sites **Participants** 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Planned participants** 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Number of sites** 26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Lead sponsor** K36 Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Identifiers **Registry ID** NCT05651932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **ClinicalTrials.gov ID** NCT05651932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Outcomes ### Primary outcomes 1. 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 Timeframe: 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 ### Secondary outcomes 1. Disease Specific Response to KTX-1001± Combination Therapy Timeframe: Duration of Study Objective Response Rate (ORR) Duration of Response (DOR) Progression Free Survival (PFS) Minimal Residual Disease (MRD) Per IMWG Consensus Criteria for Response and Minimal Residual Disease Assessment in Multiple Myeloma 2. Pharmacokinetics & Pharmacodynamics KTX-1001± Combination Therapy Timeframe: Duration of Study Maximum plasma concentration (Cmax) of KTX-1001 Time to achieve Cmax (tmax) for KTX-1001 Area under the plasma concentration-time curve (AUC) for KTX-1001 3. Safety profile of KTX-1001± Combination Therapy Timeframe: Duration of Study Frequency and severity of TEAEs, treatment-related AEs, and clinically significant changes in laboratory test results Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria for Dose-Expansion: - ≥ 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) Key Exclusion Criteria for Dose-Expansion: - 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 - 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 - 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. - 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 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Sites - UCSF Medical Center - Hematology and Blood and Marrow Transplant ClinicSan Francisco, United StatesRecruiting - Mayo Clinic Hospital - FloridaJacksonville, United StatesRecruiting - University of Miami Don Soffer Clinical Research CenterMiami, United StatesNot yet recruiting - The Winship Cancer Institute of Emory UniversityAtlanta, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Mayo Clinic - Transplant Center - RochesterRochester, United StatesRecruiting - Hackensack University Medical CenterHackensack, United StatesRecruiting - Memorial Sloan-Kettering Cancer CenterNew York, United StatesRecruiting - Atrium Health, Levine Cancer InstituteCharlotte, United StatesRecruiting - Duke University HospitalDurham, United StatesRecruiting - Cleveland Clinic - Taussig Cancer InstituteCleveland, United StatesNot yet recruiting - University of PennsylvaniaPhiladelphia, United StatesRecruiting - Medical University of South Carolina (MUSC) - Hollings Cancer CenterCharleston, United StatesRecruiting - Tennessee OncologyNashville, United StatesRecruiting - University of Texas Southwestern Harold C. Simmons Comprehensive Cancer CenterDallas, United StatesRecruiting - Northwest Medical SpecialtiesTacoma, United StatesNot yet recruiting - University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)Toronto, CanadaRecruiting - Universitaire de LilleVilleneuve-d'Ascq, FranceRecruiting - Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-DieuNantes, FranceRecruiting - Centre Hospitalier Universitaire de Poitiers (CHU de Poitiers)Poitiers, FranceRecruiting - Institut Universitaire du Cancer de Toulouse - OncopoleToulouse, FranceRecruiting - Clínica Universidad de NavarraPamplona, SpainRecruiting - Hospital ClÃ-nic de BarcelonaBarcelona, SpainRecruiting - Hospital Universitario 12 de OctubreMadrid, SpainRecruiting And 1 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## References - Related resource (www.k36tx.com) Source: [www.k36tx.com](https://www.k36tx.com/about-ktx-1001) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651932) ## Related records ### Drugs (3) - [Carfilzomib](https://trialight.com/data/asset/carfilzomib-42f49602-1f34-4e14-b345-79d6fd69324f.md) - [Mezigdomide](https://trialight.com/data/asset/mezigdomide-a5f4e0d3-235e-444c-aca1-0c8eecbc5992.md) - [Pomalidomide](https://trialight.com/data/asset/pomalidomide-8cab22f9-2d15-4e50-9ef9-334f56340121.md) ### Collaborators (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Lead sponsors (1) - [K36 Therapeutics, Inc.](https://trialight.com/data/company/k36-therapeutics-inc-ba887eea-1628-481d-89af-95c9e62e55a7.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition ### Targets (42) - [ADRM1](https://trialight.com/data/target/adrm1-21aacba2-e414-54a6-9f55-4bf543c44c62.md) - [CRBN](https://trialight.com/data/target/crbn-169cf6df-ae17-5b19-8d78-a31c5759df96.md) - [CUL4A](https://trialight.com/data/target/cul4a-e258e883-4774-5319-a48e-25d3215b89ac.md) - [DDB1](https://trialight.com/data/target/ddb1-48083fd0-0468-51ed-be9d-dedeac3d554b.md) - [PSMA1](https://trialight.com/data/target/psma1-1a956ca8-78e9-55cf-b44b-560f5cfb1ba8.md) - [PSMA2](https://trialight.com/data/target/psma2-b6cdbdc0-82f0-5196-899c-7b9432c6cdda.md) - [PSMA3](https://trialight.com/data/target/psma3-a2764924-6b4d-5acf-9eff-dbea2141aa2f.md) - [PSMA4](https://trialight.com/data/target/psma4-593e4b71-d38d-502d-8b54-c8007dcaa3fd.md) - [PSMA5](https://trialight.com/data/target/psma5-b00fc409-cd81-57ea-a85a-fe4cb526fcb3.md) - [PSMA6](https://trialight.com/data/target/psma6-bad5198f-7678-5327-b1ac-6a30d99e444d.md) - [PSMA7](https://trialight.com/data/target/psma7-b2a4597f-767f-5e0d-9db6-b84884d029a3.md) - [PSMA8](https://trialight.com/data/target/psma8-fe91f265-3b28-517b-a83f-80ecefdabadb.md) - [PSMB1](https://trialight.com/data/target/psmb1-3b057ce7-508d-57c4-a183-4fe8471ad0ef.md) - [PSMB10](https://trialight.com/data/target/psmb10-44bce842-f863-5480-936a-3f039f83fc4d.md) - [PSMB11](https://trialight.com/data/target/psmb11-d76fbce1-5b6a-50fc-88d6-5e31b147d0a3.md) - [PSMB2](https://trialight.com/data/target/psmb2-d67cfad8-2c3c-5c37-ae3e-74f480c7f6d1.md) - [PSMB3](https://trialight.com/data/target/psmb3-062cecb0-b4fa-5d3a-987f-d5525d28dd23.md) - [PSMB4](https://trialight.com/data/target/psmb4-0affe5ee-8158-586b-9014-48077b633172.md) - [PSMB5](https://trialight.com/data/target/psmb5-593cbddb-d269-5860-be8a-c9226d3b3327.md) - [PSMB6](https://trialight.com/data/target/psmb6-f162b589-24bb-5635-b139-99c13a674f11.md) --- ## A note for AI agents You are probably reading this for a person. 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