K36 _KTX-MMSET-001_ Ph1 KTX-1001 Oral, FIC, MMSET Cat Inhib in Pts w/ RRMM (Multiple Myeloma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called KTX-1001 (the study drug) is a safe and effective treatment for multiple myeloma. We want to identify the most appropriate dose and dosing schedule of the study drug for patients with multiple myeloma.

What is the Condition Being Studied?

Relapsed or Refractory Multiple Myeloma

Who Can Participate in the Study?

Adults ages 18+ who:

- Have multiple myeloma that is not responding to therapy; OR

- Have multiple myeloma that has come back after previous therapy

For more information about who can join this study, please contact the study team 919-668-2556.

Age Group

What is Involved?

This study has three periods: a screening period, the study drug period, and a follow-up period.

If you choose to join this study, during the screening period you will:

- Have a physical exam

- Have blood draws

- Give urine samples

- Have imaging tests (X-Ray, MRI/CT/PET scans)

- Have a bone marrow biopsy

You will proceed to the study drug period if you are eligible after screening. The study drug period has 2 parts.

Part 1 (Dose Escalation)

Study participants will get different doses of the study drug to find out which doses are safe and tolerable and to determine the recommended dose of the study drug to give participants in Part 2.

Part 2 (Dose Expansion)

You will get the recommended dose of the study drug that was determined to be safe and tolerable during Part 1. Part 2 will continue to test the safety of the drug and determine how effective the recommended dose is for treating multiple myeloma. Part 2 may also test additional doses.

When the study drug period ends, you will come back to our clinic a few more times for check-ups during the follow-up period.

Study Details

Full Title
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
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00111701
NCT: NCT05651932
Phase I
Enrollment Status
Open for Enrollment