A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
NCT ID: NCT05651932
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
125 participants
INTERVENTIONAL
2023-02-22
2028-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort A (Single agent): KTX-1001 + dexamethasone
Cohort A1 (single agent): KTX-1001 at RP2D1 + dex Cohort A2 (single agent): KTX-1001 at RP2D2 + dex
Cohort A1 & A2: KTX-1001
KTX-1001: Orally for 28 days each cycle until progression. Dexamethasone: Orally once weekly
Cohort B (Mezigdomide): KTX-1001 + Mezigdomide + dex
Cohort B1 (Mezigdomide): KTX-1001 at RP2D1 + Mezigdomide + dex Cohort B2 (Mezigdomide):: KTX-1001 at RP2D2 + Mezigdomide + dex
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 C (carfilzomib/KYPROLIS®): KTX-1001 + carfilzomib + dex
Cohort C1 (carfilzomib/KYPROLIS®): KTX-1001 at RP2D1 + carfilzomib + dex Cohort C2 (carfilzomib/KYPROLIS®): KTX-1001 at RP2D2 + carfilzomib + dex
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 (pomalidomide): KTX-1001 + pomalidomide + dex
Cohort D (pomalidomide): KTX-1001 at RP2D1 or RP2D2 + pomalidomide + dex
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
K36 Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic
San Francisco, California, United States
Mayo Clinic Hospital - Florida
Jacksonville, Florida, United States
The Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic - Transplant Center - Rochester
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Atrium Health, Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States
University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)
Toronto, Ontario, Canada
Universitaire de Lille
Villeneuve-d'Ascq, France, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, , France
Centre Hospitalier Universitaire de Poitiers (CHU de Poitiers)
Poitiers, , France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital ClÃ-nic de Barcelona
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Instituto de Investigacion Biomedica de Salamanca (IBSAL)
Salamanca, , Spain
Countries
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Central Contacts
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Facility Contacts
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Related Links
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K36 Therapeutics
Other Identifiers
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EUCTR No: 2022-500801-41-00
Identifier Type: OTHER
Identifier Source: secondary_id
KTX-MMSET-001
Identifier Type: -
Identifier Source: org_study_id
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