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

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Titre complet:
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
Stade ou Condition:
Multiple Myeloma Myeloma Myeloma Multiple
Phase d'étude:
Phase 1
Résumé:
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).
Description détaillée:
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.
Traitements:
Drug : KTX-1001

KTX-1001 will be administered orally, daily for 28 days.

Groupes d'étude:
Experimental : KTX-1001
KTX-1001 will be administered orally, daily for 28 days.
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Statut du recrutement:
En cours
Critères d'admissibilités:
/li>Inclusion 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) Key
Exclusion Criteria:
  • 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.
Lieux / Centres:

University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital), Toronto, Ontario – En cours

Contacts:
Name: Soo Bang
Phone: 1-347-342-7199
Email: [email protected]
Publications:
???
Date d’affichage:
2022-12-15
Date de début:
February 22, 2023
Dernière mise à jour:
2023-10-23
Nombre d'inscriptions anticipées:
60
Date de fin prévue:
2025-10-01
Date de fin prévue de l'étude primaire:
2024-12-01
Condition:
Multiple Myeloma
Myeloma
Myeloma Multiple
Genre:
All
Âge:
18 Years-N/A
Accepte des bénévoles en santé:
No
Pays participants:
Canada
France
Spain
United States
Numéro d’identification:
NCT05651932
Autres numéros d'identification de l'étude:
KTX-MMSET-001
Comité de suivi des données:
No
Produit réglementé par la FDA (É-U):
Yes
IPD Sharing Statement :
???
Responsables de l’étude:
Sponsor
Commanditaires de l’étude:
lead_sponsor
K36 Therapeutics, Inc.
Industry
Collaborators:
???
Chercheurs:
Non disponible
Protocol Registration and Results System:
???
Date de vérification:
2023-10-01