A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
NCT05651932 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2026-02-10
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).
Conditions
- Multiple Myeloma
- Myeloma
- Myeloma Multiple
Interventions
- DRUG
-
Cohort A1 & A2: KTX-1001
KTX-1001: Orally for 28 days each cycle until progression. Dexamethasone: Orally once weekly
- DRUG
-
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
- DRUG
-
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
- DRUG
-
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
Sponsors & Collaborators
- collaborator INDUSTRY
-
K36 Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-22
- Primary Completion
- 2027-12-31
- Completion
- 2028-06-30
- FDA Drug
- Yes
Countries
- United States
- Canada
- France
- Spain
Study Locations
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