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Study of KTX-1001 for Relapsed and Refractory Multiple Myeloma

This study is testing KTX-1001, a new oral medication, for people with multiple myeloma (a type of blood cancer) that has returned or not responded to previous treatments. KTX-1001 works by targeting a specific protein (MMSET) involved in cancer growth. You might receive KTX-1001 alone or in combination with other approved multiple myeloma treatments like mezigdomide, carfilzomib (KYPROLIS®), or pomalidomide (Pomalyst, Imnovid). The main goals are to find the safest and most effective dose of KTX-1001 and to see how well it works, especially when combined with other therapies. To join, you must be at least 18 years old, have multiple myeloma, and have received 1 to 3 prior treatments including specific types of drugs. The current status of this study is unclear, and it plans to enroll 165 participants.

Study design
This is a Phase I, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves dose escalation to find the right dose, followed by an expansion phase to gather more information.
What's involved
You would take KTX-1001 orally for 28 days each cycle until your disease progresses. Depending on your assigned group, you might also take other medications orally or receive them intravenously (IV) once weekly.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate the effects of KTX-1001 and combination therapies at Cycle 1 (28 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05651932

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
K36 Therapeutics, Inc.
~165 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Cohort A1 & A2: KTX-1001Cohort B1 & B2: KTX-1001+MezigdomideCohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®)Cohort D: KTX-1001+ pomalidomide (Pomalyst, Imnovid)

At a glance

Recruiting sites
23 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Cycle 1 (28 days)

Conditions

Multiple Myeloma
Myeloma
Myeloma Multiple

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Multiple MyelomaIGH-MMSETNSD2 wt Allele

Where it's being run

26 sites across 18 states
France4
Spain3
Florida2
Massachusetts2
North Carolina2
California1
Georgia1
Minnesota1

Who to contact

Soo Bang, MHSA
[email protected]
1-347-342-7199
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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
Participants must have a confirmed diagnosis of progressive MM (per IMWG), t(4;14) confirmed by fluorescence in situ hybridization (FISH) testing performed in a centralized Clinical Laboratory Improvement Amendments (CLIA) accredited laboratory via fresh tumor biopsy.
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)
Bone marrow plasma cells ≥ 30% (if only criterion for measurability)
Agreement to enroll into the REMS program (Cohort D- pomalidomide cohort only)

Exclusion

Treatment with the following therapies in the specified time period prior to first dose:
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
Cellular therapies ≤ 8 weeks
Autologous transplant \< 100 days
Allogenic transplant ≤ 6 months, or \> 6 months with active GVHD
Major surgery ≤ 4 weeks
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: participants with previously treated stable CNS disease are eligible, except for Cohorts B1 and B2 for which known CNS myeloma involvement is completely excluded.
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 7 days or 5 half-lives (whichever is longer) prior to first dose
Strong CYP1A2 inhibitors for patients receiving pomalidomide (Cohort D)
Active malignancy not related to myeloma requiring therapy within \< 2 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.

What this trial measures

  • 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 therapyCycle 1 (28 days)

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