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Clinical Trials in the USA / NCT05651932
Recruiting Phase 1

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

NCT05651932 · tracked via the Priya Life Science USA tracker
Sponsor
K36 Therapeutics, Inc.
Phase
Phase 1
Started
2023-02-22
Last updated
2026-08-18

Condition(s) studied

Multiple MyelomaMyelomaMyeloma Multiple

Investigational drug(s) / intervention(s)

Cohort A1 & A2: KTX-1001Cohort B1 & B2: KTX-1001+Mezigdomide →Cohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®) →Cohort D: KTX-1001+ pomalidomide (Pomalyst, Imnovid) →

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

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
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
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 Not Yet 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
Northwest Medical Specialties Tacoma Washington 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

More K36 Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

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 the USA