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
- 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
- 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)