A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
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
Sponsor: K36 Therapeutics, Inc. + Bristol-Myers Squibb
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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
Time frame: Cycle 1 (28 days)
Secondary Endpoints
Disease Specific Response to KTX-1001± Combination Therapy
Pharmacokinetics & Pharmacodynamics KTX-1001± Combination Therapy
Safety profile of KTX-1001± Combination Therapy
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) …
Read full criteria on CT.gov →✦ Analyst Commentary
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