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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 (28 days)
Awards & highlights
Study 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 belowSelect...
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.
Select...
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.
Select...
My test results show I have the t(4;14) genetic change or a specific mutation in MMSET.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 (28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 (28 days)
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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: KTX-1001Experimental Treatment1 Intervention
KTX-1001 will be administered orally, daily for 28 days.
Find a Location
Who is running the clinical trial?
K36 Therapeutics, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong acid reducers or certain other medications in the last 14 days.I can take care of myself and am up and about more than 50% of my waking hours.I have had at least 3 treatments including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.My test results show I have the t(4;14) genetic change or a specific mutation in MMSET.You have a disease that can be measured and evaluated using specific criteria.You have too much M protein in your urine.Your sFLC (free light chain) levels are higher than 10 mg/dL (100 mg/L).Your IgA levels in the blood are higher than 0.50 g/dL.You have too many abnormal plasma cells in your bone marrow.I have a tumor outside the bone marrow, larger than 1 cm, that can be monitored with scans.I have not had major surgery in the last 4 weeks.My kidney, liver, lung, or heart function is not normal.I had a stem cell transplant less than 6 months ago or have ongoing GVHD.I haven't needed treatment for any cancer other than myeloma in the last 3 years.I have not taken certain medications recently.I have an active brain or spinal cord disease.My bone marrow is not working properly.I haven't had cancer treatment like radiation or chemotherapy in the last 2 weeks.My multiple myeloma has returned or is not responding to treatment.I have not had cellular therapy in the last 8 weeks.I had a stem cell transplant using my own cells less than 100 days ago.I am 18 years old or older.I have tried all treatments for my condition without success or cannot tolerate them.I have never had plasma cell leukemia, POEMS syndrome, solitary bone lesion, myelodysplastic syndrome, myeloproliferative neoplasm, or light chain amyloidosis.I do not have any current serious infections.You have a high level of M protein in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: KTX-1001
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you outline the potential hazards of KTX-1001 use?
"Our team at Power has assigned KTX-1001 a rating of 1 due to its phase 1 status, which implies limited evidence regarding the drug's safety and efficacy."
Answered by AI
Does this experiment have any available openings for participants?
"As declared on clinicaltrials.gov, this study is actively seeking participants, with an initial post date of December 1st 2022 and a recent edit on the 13th."
Answered by AI
What is the cutoff for enrolment in this trial?
"Affirmative, according to information provided on clinicaltrials.gov this investigation is actively enrolling participants. The trial was first posted on December 1st 2022 and has been updated as recently as the 13th of that same month. Enrolment requires 60 individuals from a single medical centre."
Answered by AI
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