RECRUITING

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

Conditions

Multiple Myeloma Myeloma Myeloma Multiple NSD2 MMSET WHSC1 T4;14 T(4;14)translocation RRMM

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-02-22

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05651932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ≥ 18 years of age * ECOG score ≤ 2 * Relapsed or refractory multiple myeloma (as per IMWG) * ≥ 3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody * Patients must have exhausted available therapeutic options that are expected to provide a meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance, or refusal of the therapy * t(4;14) confirmed by standard of care FISH testing, or GOF mutation in MMSET confirmed by local sequencing test (Part B dose expansion cohorts only) * Measurable disease, including at least 1 of the following criteria: * Serum M protein ≥ 0.50 g/dL (by SPEP) * Serum IgA ≥ 0.50 g/dL (IgA myeloma patients) * Urine M protein ≥ 200 mg/24 h (by UPEP) * sFLC involved light chain ≥ 10 mg/dL (100 mg/L) (patients with abnormal sFLC ratio) * ≥ 1 extramedullary lesion ≥ 1 cm in size and able to be followed by imaging assessments (Part A dose escalation cohorts only) * Bone marrow plasma cells ≥ 10% (Part A dose escalation cohorts only)	* Treatment with the following therapies in the specified time period prior to first dose: * Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks * Cellular therapies ≤ 8 weeks * Autologous transplant \< 100 days * Allogenic transplant ≤ 6 months, or \> 6 months with active GVHD * Major surgery ≤ 4 weeks * History of or current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis * Active CNS disease * Inadequate bone marrow function * Inadequate renal, hepatic, pulmonary, and cardiac function * Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocol. * Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 14 days or 5 half-lives prior to first dose * Active malignancy not related to myeloma requiring therapy within \< 3 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.

Inclusion Criteria

Exclusion Criteria

* ≥ 18 years of age
* ECOG score ≤ 2
* Relapsed or refractory multiple myeloma (as per IMWG)
* ≥ 3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody
* Patients must have exhausted available therapeutic options that are expected to provide a meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance, or refusal of the therapy
* t(4;14) confirmed by standard of care FISH testing, or GOF mutation in MMSET confirmed by local sequencing test (Part B dose expansion cohorts only)
* Measurable disease, including at least 1 of the following criteria:
* Serum M protein ≥ 0.50 g/dL (by SPEP)
* Serum IgA ≥ 0.50 g/dL (IgA myeloma patients)
* Urine M protein ≥ 200 mg/24 h (by UPEP)
* sFLC involved light chain ≥ 10 mg/dL (100 mg/L) (patients with abnormal sFLC ratio)
* ≥ 1 extramedullary lesion ≥ 1 cm in size and able to be followed by imaging assessments (Part A dose escalation cohorts only)
* Bone marrow plasma cells ≥ 10% (Part A dose escalation cohorts only)

* Treatment with the following therapies in the specified time period prior to first dose:
* Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
* Cellular therapies ≤ 8 weeks
* Autologous transplant \< 100 days
* Allogenic transplant ≤ 6 months, or \> 6 months with active GVHD
* Major surgery ≤ 4 weeks
* History of or current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis
* Active CNS disease
* Inadequate bone marrow function
* Inadequate renal, hepatic, pulmonary, and cardiac function
* Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocol.
* Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 14 days or 5 half-lives prior to first dose
* Active malignancy not related to myeloma requiring therapy within \< 3 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.

Contacts and Locations

Study Contact

Soo Bang

CONTACT

1-347-342-7199

sbang@k36tx.com

Sanjana Miskin

CONTACT

1-973-214-8160

smiskin@k36tx.com

Study Locations (Sites)

Mayo Clinic Hospital - Phoenix

Phoenix, Arizona, 85259

United States

UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic

San Francisco, California, 94143

United States

Mayo Clinic Hospital - Florida

Jacksonville, Florida, 32224

United States

The Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

United States

University of Kansas Cancer Center - Fairway

Westwood, Kansas, 66205

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Mayo Clinic - Transplant Center - Rochester

Rochester, Minnesota, 55905

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

United States

Duke University Hospital

Durham, North Carolina, 27705

United States

Tennessee Oncology

Nashville, Tennessee, 37203

United States

University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, 75235

United States

Collaborators and Investigators

Sponsor: K36 Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-22

Study Completion Date2025-10

Study Record Updates

Study Start Date2023-02-22

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

NSD2
MMSET
WHSC1
T4;14
T(4;14)
translocation
myeloma
RRMM

Additional Relevant MeSH Terms

Multiple Myeloma
Myeloma
Myeloma Multiple