Phase 1 Study of KTX-1001, an Oral MMSET Inhibitor for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety of KTX-1001, a new oral drug that selectively inhibits the MMSET enzyme involved in multiple myeloma, in adults with relapsed or refractory multiple myeloma RRMM. This Phase I study aims to find the best dose and understand how the drug works alone and combined with other therapies in patients with a specific genetic change called t414. The study has two parts a dose escalation phase where different doses of KTX-1001 are tested over 28-day cycles to find the recommended dose and maximum tolerated dose and a dose expansion phase where patients receive KTX-1001 alone or combined with Mezigdomide, dexamethasone, carfilzomib, or pomalidomide. Treatments are given orally or by infusion depending on the combination, with dexamethasone taken once weekly. Participants will be monitored for response to treatment, drug safety, and how their bodies process the drug through regular assessments during the study. The main outcomes include determining the recommended dose and initial effectiveness of KTX-1001 combinations. The study is expected to continue until June 2028, with ongoing evaluations throughout treatment cycles.

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