Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Alfred Chung (ucsf)
Headshot of Alfred Chung
Alfred Chung

Description

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).

Official 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

Details

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 t(4;14) will receive KTX-1001 at the RP2D alone and in combination with SOC therapy (dexamethasone, carfilzomib or pomalidomide) to further define safety and tolerability and provide preliminary efficacy information.

Keywords

Multiple Myeloma, Myeloma, Myeloma Multiple, NSD2, MMSET, WHSC1, T4;14, T(4;14), translocation, RRMM, Plasma Cell Neoplasms, Dexamethasone, Dexamethasone acetate, Pomalidomide, BB 1101, Cohort A1 & A2, Cohort C1 & C2, Cohort D

Eligibility

Locations

  • UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic accepting new patients
    San Francisco California 94143 United States
  • University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center accepting new patients
    Dallas Texas 75235 United States

Lead Scientist at University of California Health

  • Alfred Chung (ucsf)
    Dr. Alfred Chung is a hematologist-oncologist who cares for patients with blood cancers, including leukemias, lymphomas and myelomas. He sees patients who are in the hospital for treatment, including those who need a bone marrow transplant and those receiving chemotherapy or cellular therapies to bolster the immune system.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
K36 Therapeutics, Inc.
Links
K36 Therapeutics
ID
NCT05651932
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 125 study participants
Last Updated