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New pill takes aim at Hard-to-Treat myeloma

NCT ID NCT05651932

Disease control Sponsor: K36 Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This early-stage trial tests an experimental oral drug called KTX-1001 in people with multiple myeloma that has returned or not responded to prior treatments. The drug works by blocking a protein that helps myeloma cells grow. The study will enroll 165 adults and will also test KTX-1001 combined with other myeloma drugs. The main goals are to find a safe dose and see if the drug shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KTX-1001 (an oral drug that targets a protein linked to myeloma growth), sometimes combined with dexamethasone, mezigdomide, or carfilzomib
What this could lead to
If successful, this could provide a new treatment option for patients with multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 165 participants, so the drug may prove unsafe or ineffective. It is not a cure and patients will need ongoing treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 165 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria for Dose-Expansion: * ≥ 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) Key Exclusion Criteria for Dose-Expansion: * 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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma plasma cell neoplasm refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma Myeloma Myeloma multiple

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health, Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu

    RECRUITING

    Nantes, France

  • Centre Hospitalier Universitaire de Poitiers (CHU de Poitiers)

    RECRUITING

    Poitiers, France

  • Cleveland Clinic - Taussig Cancer Institute

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clínica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital ClÃ-nic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    RECRUITING

    Toulouse, France

  • Instituto de Investigacion Biomedica de Salamanca (IBSAL)

    RECRUITING

    Salamanca, Spain

    Contact Email: •••••@•••••

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Transplant Center - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Hospital - Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina (MUSC) - Hollings Cancer Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan-Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Northwest Medical Specialties

    NOT_YET_RECRUITING

    Tacoma, Washington, 98405, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic

    RECRUITING

    San Francisco, California, 94143, United States

  • Universitaire de Lille

    RECRUITING

    Villeneuve-d'Ascq, France, France

  • University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University of Miami Don Soffer Clinical Research Center

    NOT_YET_RECRUITING

    Miami, Florida, 33136, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center

    RECRUITING

    Dallas, Texas, 75235, United States

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