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.
Who Can Participate?
Eligibility
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.
- 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.
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.
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
Cristina
Gasparetto
Protocol Number
PRO00111701
NCT ID
NCT05651932
Phase
I
Enrollment Status
OPEN TO ACCRUAL