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
404-778-5180
winshipcancer.emory.edu

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