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Histone Lysine Methyltransferase Inhibitor

MMSET Inhibitor for Multiple Myeloma

Phase 1
Recruiting
Research Sponsored by K36 Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age
ECOG score ≤ 2
Must not have
Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
Cellular therapies ≤ 8 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 (28 days)
Awards & highlights

Summary

This trial tests a new drug to treat a type of cancer (Multiple Myeloma) in patients with relapsed or refractory disease.

Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who have tried all other treatments without success. They must have certain levels of M protein in their urine or blood, and some may need to show specific genetic changes related to their cancer. People can't join if they've had a recent transplant, major surgery, other active cancers, inadequate organ function, or certain infections.Check my eligibility
What is being tested?
The study tests KTX-1001, an oral drug designed to inhibit MMSET activity in patients with multiple myeloma that has come back after treatment or hasn't responded to therapy. It's a Phase I trial focused on safety and how well the body tolerates the drug.See study design
What are the potential side effects?
While not specified here, side effects could include typical reactions seen with cancer therapies such as nausea, fatigue, liver issues (due to metabolism of the drug), potential blood disorders (as it affects bone marrow cells), and possibly unique effects from inhibiting MMSET.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My multiple myeloma has returned or is not responding to treatment.
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I have had at least 3 treatments including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
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I have tried all treatments for my condition without success or cannot tolerate them.
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My test results show I have the t(4;14) genetic change or a specific mutation in MMSET.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had cancer treatment like radiation or chemotherapy in the last 2 weeks.
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I have not had cellular therapy in the last 8 weeks.
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I had a stem cell transplant using my own cells less than 100 days ago.
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I have never had plasma cell leukemia, POEMS syndrome, solitary bone lesion, myelodysplastic syndrome, myeloproliferative neoplasm, or light chain amyloidosis.
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I have an active brain or spinal cord disease.
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My bone marrow is not working properly.
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My kidney, liver, lung, or heart function is not normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 (28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 (28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicity (DLTs)
Secondary outcome measures
Area under the plasma concentration-time curve (AUC) for KTX-1001
Duration of response (DOR) for KTX-1001
Maximum plasma concentration (Cmax) of KTX-1001
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: KTX-1001Experimental Treatment1 Intervention
KTX-1001 will be administered orally, daily for 28 days.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Multiple Myeloma include proteasome inhibitors (e.g., bortezomib), which block the proteasome's ability to degrade proteins, leading to cancer cell death; immunomodulatory drugs (e.g., lenalidomide), which enhance the immune system's ability to attack myeloma cells; and monoclonal antibodies (e.g., daratumumab), which target specific proteins on the surface of myeloma cells to induce immune-mediated destruction. Novel agents like histone deacetylase inhibitors and MMSET inhibitors (which prevent H3K36 dimethylation) target epigenetic modifications to disrupt cancer cell growth and survival. These treatments are crucial as they offer multiple mechanisms to combat the disease, potentially overcoming resistance and improving patient outcomes.
Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Novel direct and indirect cyclin-dependent kinase modulators for the prevention and treatment of human neoplasms.New drugs in multiple myeloma.

Find a Location

Who is running the clinical trial?

K36 Therapeutics, Inc.Lead Sponsor

Media Library

KTX-1001 (Histone Lysine Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05651932 — Phase 1
Multiple Myeloma Research Study Groups: KTX-1001
Multiple Myeloma Clinical Trial 2023: KTX-1001 Highlights & Side Effects. Trial Name: NCT05651932 — Phase 1
KTX-1001 (Histone Lysine Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05651932 — Phase 1
~11 spots leftby Dec 2024