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

Active:	Yes
Cancer Type:	Multiple Myeloma	NCT ID:	NCT05651932
Trial Phases:	Phase I	Protocol IDs:	KTX-MMSET-001 (primary) NCI-2023-01697 EUCTR No: 2022-500801-41-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	K36 Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05651932

Summary

A Phase I study to evaluate the safety of a novel, orally available, selective, and
potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also
known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with
relapsed or refractory multiple myeloma (RRMM).

Objectives

This is a Phase I, open-label, dose escalation and expansion study in adult patients with
RRMM.

In the dose escalation phase (Part A), patients will be evaluated for DLTs during Cycle 1
(28 days). The KTX-1001 MTD, RP2D, and schedule will be determined.

In the dose expansion phase (Part B), patients with translocation t(4;14) or a GOF
mutation in MMSET (eg, E1099K) will be enrolled. Patients will receive KTX-1001 at the
RP2D to further define safety and tolerability and provide preliminary efficacy
information.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.