A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorK36 Therapeutics, Inc.
About this trial
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
Qualifiers
≥ 18 years of age
ECOG score ≤ 1
Multiple myeloma (as per IMWG)
Prior therapy for MM: Participants must have received at least 1 and up to 3 prior lines of therapy as defined by IMWG, and the following drug classes: PI, IMiD, and anti-CD38 antibody. For mezigdomide combination Cohorts B1 and B2, participants must have received at least 2 prior lines of therapy
Disqualifiers
Patients in Cohorts B1 and B2 must not have received prior mezigdomide treatment
Carfilzomib in the immediate last prior line of therapy for patients enrolled in Cohorts C1 and C2
Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D
Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
Trial design
Treatments tested in this trial
- Cohort A1 & A2: KTX-1001
- Cohort B1 & B2: KTX-1001+Mezigdomide
- Cohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®)
- Cohort D: KTX-1001+ pomalidomide (Pomalyst, Imnovid)
Treatment groups
165 Participants
are divided into 4 treatment groupsSponsors and collaborators
K36 Therapeutics, Inc.
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov