The Phase l trial will evaluate KTX-1001 to treat relapsed or refractory multiple myeloma. Credit: www.scientificanimations.com / commons.wikimedia.org.

K36 Therapeutics has dosed the first patient in a Phase l trial of KTX-1001 for the treatment of relapsed or refractory multiple myeloma (RRMM).

Lead principal investigator of the trial and director of Myeloma Research for SCRI at Tennessee Oncology, Jesus Berdeja, has dosed the patient in Nashville, Tennessee, US.

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The Phase l trial is an open-label, dose escalation and expansion study.

It will assess the safety, tolerability, pharmacology, and initial clinical activity of KTX-1001 to prevent the dimethylation of H3K36 in adult RRMM patients.  

In the dose escalation stage or Part A of the trial, patients will be investigated for incidence of dose-limiting toxicities (DLTs) during cycle one (28 days).

The KTX-1001 MTD, RP2D, and schedule will also be determined.

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In Part B or the dose expansion stage, patients with translocation t(4;14) or a GOF mutation in MMSET will be included.

They will be given KTX-1001 at the RP2D to further determine the safety and tolerability as well as offer preliminary efficacy data.

The trial plans to include 60 subjects, with an aim to complete the same by October 2025.

K36 Therapeutics CEO Terry Connolly said: “KTX-1001 has not only demonstrated encouraging preclinical activity and a favourable tolerability profile, but it also addresses unmet need for patients who have received other standard of care therapies available to patients suffering from multiple myeloma.

“We look forward to working with all our sites, investigators, and study teams to efficiently enrol our Phase l clinical trial.”