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

ConditionsMultiple MyelomaMyelomaMyeloma Multiple
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Cohort A1 & A2: KTX-1001

    Drug

    KTX-1001: Orally for 28 days each cycle until progression. Dexamethasone: Orally once weekly

  • Cohort B1 & B2: KTX-1001+Mezigdomide

    Drug

    Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once weekly Drug: Mezigdomide Dexamethasone: Orally once weekly

  • Cohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®)

    Drug

    Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once weekly Drug: Carfilzomib (KYPROLIS®): IV, once weekly for 3 weeks in each 28-day cycle

  • Cohort D: KTX-1001+ pomalidomide (Pomalyst, Imnovid)

    Drug

    Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once a week Drug: Pomalidomide (Pomalyst, Imnovid): Orally, for 21 days in each 28-day cycle

Treatment groups

165 Participants
are divided into 4 treatment groups
Group A: Cohort A (Single agent): KTX-1001 + dexamethasoneExperimental treatment 1 intervention
Group B: Cohort B (Mezigdomide): KTX-1001 + Mezigdomide + dexExperimental treatment 1 intervention
Group C: Cohort C (carfilzomib/KYPROLIS®): KTX-1001 + carfilzomib + dexExperimental treatment 1 intervention
Group D: Cohort D (pomalidomide): KTX-1001 + pomalidomide + dexExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Escalation: Determination of Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose (MTD) Dose Expansion: Provide preliminary efficacy data on the antitumor effects of KTX-1001 in combination with other anti-myeloma therapy

Incidence of dose-limiting toxicity (DLTs), treatment-emergent adverse events (TEAEs), treatment-related AEs, and clinically significant changes in laboratory test results

Time frame
Cycle 1 (28 days)

Secondary outcomes

1

Disease Specific Response to KTX-1001± Combination Therapy

Objective Response Rate (ORR) Duration of Response (DOR) Progression Free Survival (PFS) Minimal Residual Disease (MRD) Per IMWG Consensus Criteria for Response and Minimal Residual Disease Assessment in Multiple Myeloma

Time frame
Duration of Study
2

Pharmacokinetics & Pharmacodynamics KTX-1001± Combination Therapy

Maximum plasma concentration (Cmax) of KTX-1001 Time to achieve Cmax (tmax) for KTX-1001 Area under the plasma concentration-time curve (AUC) for KTX-1001

Time frame
Duration of Study
3

Safety profile of KTX-1001± Combination Therapy

Frequency and severity of TEAEs, treatment-related AEs, and clinically significant changes in laboratory test results

Time frame
Duration of Study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

K36 Therapeutics, Inc.

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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