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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
ECOG (0 to 3)
Diagnosed with one of the following pathologic diagnoses of SM-AHN: Myelodysplastic syndrome (MDS) that is high- or very high-risk, Accelerated phase myeloproliferative neoplasm (MPN), MDS with excessive blasts in bone marrow or peripheral blood, Chronic myelomonocytic leukemia-2 (CMML-2) (High-Risk Cohort)
Must not have
Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives, whichever is longer, before the first dose of study drug
Need for treatment with high dose steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing CGT9486, a potential new treatment, for people with a certain type of mastocytosis, which is a disease where too many mast cells build up in the body.

Who is the study for?
This trial is for patients with Advanced Systemic Mastocytosis, including Aggressive SM, SM with an Associated Hematologic Neoplasm, or Mast Cell Leukemia. Participants must have measurable disease and be in a stable enough condition (ECOG 0 to 3). They can't join if they have HIV, hepatitis B/C, other recent cancers, significant heart issues or bleeding events, unresolved toxicity from past treatments or need certain medications like strong CYP3A4 inhibitors.
What is being tested?
The study is testing Bezuclastinib's effectiveness on Advanced Systemic Mastocytosis. It's an open-label Phase 2 trial where all participants receive the drug. The goal is to see how well it treats different types of this mast cell cancer by monitoring changes in the disease according to specific criteria.
What are the potential side effects?
Potential side effects of Bezuclastinib are not detailed here but may include typical reactions seen with cancer therapies such as nausea, fatigue, blood count changes and increased risk of infections. Specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do heavy physical work.
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I have been diagnosed with a high-risk blood disorder.
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I have been diagnosed with a severe form of mastocytosis.
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I am receiving or need therapy for advanced heart failure.
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My condition worsened while on bezuclastinib, needing urgent treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken strong CYP3A4 affecting drugs recently.
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I need to take high dose steroids for my condition.
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I still have side effects from previous AdvSM therapy that are not mild.
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My tests show I have the FIP1L1-PDGFRA gene fusion.
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I have been diagnosed with acute myeloid leukemia (AML).
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I need immediate cancer treatment for my blood-related cancer.
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I have a serious heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in histopathologic findings in blood and bone marrow
Change in spleen and liver volume by imaging
Duration of Response (DOR)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: bezuclastinibExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Cogent Biosciences, Inc.Lead Sponsor
9 Previous Clinical Trials
843 Total Patients Enrolled
Jessica Sachs, MDStudy DirectorCogent Biosciences, Inc.
6 Previous Clinical Trials
746 Total Patients Enrolled
Rachael Easton, MD, Ph.D.Study DirectorCogent Biosciences, Inc.

Media Library

Bezuclastinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04996875 — Phase 2
Systemic Mastocytosis Research Study Groups: bezuclastinib
Systemic Mastocytosis Clinical Trial 2023: Bezuclastinib Highlights & Side Effects. Trial Name: NCT04996875 — Phase 2
Bezuclastinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04996875 — Phase 2
~20 spots leftby Jul 2025
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