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Tyrosine Kinase Inhibitor

Bezuclastinib for Systemic Mastocytosis

Phase 2
Recruiting
Research Sponsored by Cogent Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For patients receiving corticosteroids, the dose must be ≤10 mg/day of prednisone or equivalent
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
Must not have
Diagnosed with mastocytosis of the skin without systemic involvement
Diagnosed with bone marrow mastocytosis, advanced systemic mastocytosis including SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia, or mast cell sarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Summary

This trial is testing a new drug for people with a mastocytosis, to see if it is safe and effective. The study will have three parts, and patients will either receive the new drug or a placebo.

Who is the study for?
This trial is for patients with a condition called systemic mastocytosis, specifically the indolent or smoldering types. Participants should have moderate-to-severe symptoms despite current treatments and be in fairly good health overall (ECOG 0-2). They can't join if they've had significant bleeding recently, need blood thinners, have certain advanced forms of the disease, skin-only mastocytosis, previous KIT inhibitor therapy (except approved ones), recent cytoreductive therapy or radiation.Check my eligibility
What is being tested?
The study tests bezuclastinib tablets against placebo tablets to see which is better at managing systemic mastocytosis when added to standard care. It's randomized and double-blind meaning neither doctors nor patients know who gets the real drug versus placebo. The trial has three parts; after completing Parts 1a/1b/2 with either drug or placebo, participants may move on to Part 3 for bezuclastinib treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks might include allergic reactions to medication components, potential liver issues since it's processed by the body there, digestive disturbances like nausea or diarrhea as common with oral drugs and possible fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking 10 mg or less of prednisone daily or its equivalent.
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I can take care of myself and am up and about more than half of my waking hours.
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I have moderate-to-severe symptoms despite taking at least 2 treatments for 14 days.
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I have been diagnosed with a slow-progressing form of systemic mastocytosis.
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I have been diagnosed with Smoldering systemic mastocytosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with mastocytosis that affects only my skin.
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I have been diagnosed with a type of advanced mastocytosis.
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I haven't had serious bleeding or needed blood-thinning medication in the last month.
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I need more than 10 mg/day of prednisone or its equivalent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Determine recommended dose of bezuclastinib (CGT9486) in subjects with NonAdvSM
Part 2: Efficacy of bezuclastinib at the selected dose versus placebo
Part 3: Safety and tolerability of bezuclastinib as assessed by number of adverse events
Secondary outcome measures
Assess the pharmacokinetics (PK) of bezuclastinib in subjects with NonAdvSM
Change and percent change in 12-item Short Form Health Survey (SF-12)
Change and percent change in EuroQol 5 Dimensions 5 Levels (EQ 5D-5L)
+10 more

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: (Part 3) Bezuclastinib + BSCExperimental Treatment2 Interventions
Group II: (Part 2) Bezuclastinib Selected Dose + BSCExperimental Treatment1 Intervention
Group III: (Part 1b) Bezuclastinib Dose 2 + BSCExperimental Treatment1 Intervention
Group IV: (Part 1b) Bezuclastinib Dose 1 + BSCExperimental Treatment1 Intervention
Group V: (Part 1a) Bezuclastinib Dose 2 + BSCExperimental Treatment1 Intervention
Group VI: (Part 1a) Bezuclastinib Dose 1 + BSCExperimental Treatment1 Intervention
Group VII: (Part 2) Placebo + BSCPlacebo Group1 Intervention
Group VIII: (Part 1a) Placebo + BSCPlacebo Group1 Intervention
Group IX: (Part 1b) Placebo + BSCPlacebo Group1 Intervention

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
Selective tyrosine kinase inhibitors (TKIs) like Bezuclastinib work by inhibiting specific enzymes involved in the signaling pathways that cause the proliferation and survival of mast cells. In Systemic Mastocytosis (SM), mutations in the KIT gene lead to uncontrolled mast cell growth. TKIs target these enzymes, reducing mast cell proliferation and alleviating symptoms. This mechanism is crucial for SM patients as it addresses the root cause of the disease, potentially leading to better symptom control and improved quality of life.
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Find a Location

Who is running the clinical trial?

Cogent Biosciences, Inc.Lead Sponsor
9 Previous Clinical Trials
760 Total Patients Enrolled
Jessica Sachs, MDStudy DirectorCogent Biosciences
6 Previous Clinical Trials
663 Total Patients Enrolled
Rachael Easton, MD, PhDStudy DirectorCogent Biosciences

Media Library

Bezuclastinib (CGT9486) (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05186753 — Phase 2
Systemic Mastocytosis Research Study Groups: (Part 1b) Bezuclastinib Dose 1 + BSC, (Part 2) Bezuclastinib Selected Dose + BSC, (Part 2) Placebo + BSC, (Part 3) Bezuclastinib + BSC, (Part 1a) Bezuclastinib Dose 1 + BSC, (Part 1a) Bezuclastinib Dose 2 + BSC, (Part 1a) Placebo + BSC, (Part 1b) Bezuclastinib Dose 2 + BSC, (Part 1b) Placebo + BSC
Systemic Mastocytosis Clinical Trial 2023: Bezuclastinib (CGT9486) Highlights & Side Effects. Trial Name: NCT05186753 — Phase 2
Bezuclastinib (CGT9486) (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05186753 — Phase 2
~15 spots leftby Nov 2024