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Apex Trial for AdvSM Now Enrolling

The Apex clinical trial is a Phase 2 clinical trial evaluating an investigational medication bezuclastinib (CGT9486) in people with AdvSM.  Bezuclastinib is designed to selectively and potently target the gene, KIT D816V, known to drive AdvSM in most cases. The investigational medication is in the form of a pill to be taken orally every day.  The study aims to identify the optimal, safe dose of bezuclastinib and  to slow the progression of the disease, as measured by safety and efficacy criteria.

Advanced Systemic Mastocytosis Clinical Trial: Now Enrolling

The Apex Clinical Trial is currently enrolling patients diagnosed with Advanced Systemic Mastocytosis (AdvSM), a rare, aggressive, life-threatening disease that occurs when mast cells accumulate in organs and tissues of the bodyg. This Phase 2 open-label, multicenter study is evaluating the safety and efficacy of bezuclastinib in patients with AdvSM.

Apex is an open-label, two-part Phase 2 study investigating bezuclastinib, a selective and potent KIT inhibitor, for the treatment of patients with AdvSM, including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

Your Patient may be eligible for the Apex clinical trial if

Key Inclusion

  • Diagnosed with one of the following types of systemic mastocytosis:
    • Aggressive Systemic Mastocytosis (ASM)
    • Advanced Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)
    • Mast Cell Leukemia (MCL)
  • 18 years of age or older
  • Not pregnant or breastfeeding

About AdvSM, a rare type of mastocytosis:

Advanced systemic mastocytosis (AdvSM) is a rare, aggressive, life-threatening disease that occurs when mast cells accumulate in organs and tissues of the body.o Mast cells are a type of white blood cell that are part of your immune system. Mast cells are important in allergic reactions and fighting infections. In most cases, the abnormal accumulation of mast cells is caused by a genetic mutation in the KIT tyrosine receptor kinase gene, specifically KIT D816V. p Diagnosis is difficult and current treatments approved by the FDA and other healthcare authorities have side effects which have limited dosing and availability of these treatments. q,r,s

Patients with AdvSM may suffer from a number of debilitating symptoms such as: t

  • Fatigue
  • Nausea, Abdominal Pain, and other gastrointestinal symptoms
  • Low blood counts
  • Bone pain and/or fractures
  • Abnormal liver function and/or enlargement of the liver
  • Enlargement of the spleen and/or lymph nodes
  • Muscle or joint pain
  • Headaches and/or difficulty concentrating
  • Itching, Skin redness/swelling, Flush episodes (reddening of the face/sudden feeling of warmth)

Summit Trial Now Enrolling

The Summit clinical trial is a placebo-controlled Phase 2 clinical study evaluating an investigational medication bezuclastinib (CGT9486) in people with NonAdvSM. Bezuclastinib is designed to selectively and potently target KIT D816V, the gene which is known to drive NonAdvSM in most cases. The investigational medication is in the form of a pill to be taken orally. Patients will continue to receive their current medication(s) for their NonAdvSM, known as their best supportive care, while they participate in this clinical trial. The study aims to identify an optimal, safe dose of bezuclastinib and to determine the efficacy of bezuclastinib.

Your Patient may be eligible for the Summit clinical trial if:

Key Inclusion

  • Diagnosed with one (1) of the following forms of NonAdvSM:
      1.  Indolent Systemic Mastocytosis (ISM)
      2.  Smoldering Systemic Mastocytosis (SSM)
  • Eighteen (18) years of age or older
  • Not pregnant or breastfeeding

About NonAdvSM, a rare type of mastocytosis:

Nonadvanced systemic mastocytosis (NonAdvSM) is a group of rare, life-long diseases caused by an accumulation of mast cells in organs and tissues, causing severely debilitating and potentially life-threatening symptoms. Mast cells are a type of immune cell that are important in fighting infections and cause many of the symptoms of allergic reactions. Indolent Systemic Mastocytosis (ISM) and Smoldering Systemic Mastocytosis (SSM) are both considered forms of NonAdvSM and in most cases, are caused by a genetic mutation in the KIT tyrosine receptor kinase gene, specifically KIT D816V. Diagnosis for NonAdvSM is difficult and currently there are no available disease-specific treatments for patients.

Patients with NonAdvSM may suffer from a number of chronic symptoms such as:u

  • Itchy skin, skin lesions, skin redness and warmth (flushing)
  • Wheezing, shortness of breath
  • Fatigue
  • Anaphylaxis
  • Abdominal pain, bloating, diarrhea, nausea, vomiting
  • Brain fog, dizziness, memory impairment, mood changes, or trouble concentrating
  • Bone and joint pain

About Bezuclastinib:

Bezuclastinib (also known as CGT9486), is a tyrosine kinase inhibitor that is designed to selectively and potently target exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V which is known to drive AdvSM in most cases. Bezuclastinib pills are taken orally every day in 28-day cycles.

About Cogent Biosciences

Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting FGFR2 and ErbB2. Cogent Biosciences is based in Cambridge, MA, and Boulder, CO. Visit our website for more information at www.cogentbio.com.

Learn More about the Systemic Mastocytosis (SM) Clinical Trials

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If you are interested in learning more about the SM Clinical Trials, including how your patient(s) may participate, please call 1-833-411-MYSM (1-833-411-6976) to leave a message or fill out the form below to have a qualified healthcare professional get in contact with you:

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