NCT05651932 A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
| NCT ID | NCT05651932 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | K36 Therapeutics, Inc. |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2023-02-22 |
| Primary Completion | 2027-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Key Inclusion Criteria for Dose-Expansion: * ≥ 18 years of age * 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) Key Exclusion Criteri