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Back|NCT05651932Recruiting
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

Phase
Phase 1
Sponsor
K36 Therapeutics, Inc.
Enrollment
125
Timeline
Feb 2023 → Jun 2026
About This Study

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).

Eligibility Criteria

Inclusion Criteria

  • 1≥ 18 years of age
  • 2ECOG score ≤ 1
  • 3Multiple myeloma (as per IMWG)
  • 4≥ 3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody
  • 5Patients must be refractory to their last prior therapy
  • 6Cohorts A1/A2: 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
  • 7t(4;14) confirmed by standard of care FISH testing
  • 8Measurable disease, including at least 1 of the following criteria:
  • 9Serum M protein ≥ 0.50 g/dL (by SPEP)
  • 10Serum IgA ≥ 0.50 g/dL (IgA myeloma patients)
  • 11Urine M protein ≥ 200 mg/24 h (by UPEP)
  • 12sFLC involved light chain ≥ 10 mg/dL (100 mg/L) (patients with abnormal sFLC ratio)
  • 13Bone marrow plasma cells ≥ 30% (if only criterion for measurability)
  • 14Agreement to enroll into the REMS program (Cohort D- pomalidomide cohort only)

Exclusion Criteria

  • 1Treatment with the following therapies in the specified time period prior to first dose:
  • 2Carfilzomib in the immediate last prior line of therapy for patients enrolled in Cohorts C1 and C2
  • 3Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D
  • 4Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
  • 5Cellular therapies ≤ 8 weeks
  • 6Autologous transplant \< 100 days
  • 7Allogenic transplant ≤ 6 months, or \> 6 months with active GVHD
  • 8Major surgery ≤ 4 weeks
  • 9Current 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
  • 10MM with extramedullary disease (applies to Cohorts A1 \& A2: KTX-1001, C1 \& C2: Carfilzomib, and D: Pomalidomide only)
  • 11Active CNS disease
  • 12Inadequate bone marrow function
  • 13Inadequate renal, hepatic, pulmonary, and cardiac function
  • 14Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocol.
  • 15Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 14 days or 5 half-lives prior to first dose
  • 16Strong CYP1A2 inhibitors for patients receiving pomalidomide (Cohort D)
  • 17Active malignancy not related to myeloma requiring therapy within \< 2 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.

Locations

21 sites participating in this study

The Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

Sagar Lonial, MD, FACP

UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic

San Francisco, California 94143

Recruiting

Alfred Chung, MD

Mayo Clinic Hospital - Florida

Jacksonville, Florida 32224

Recruiting

Vivek Roy, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →