A Study of CGT9486 in Patients with Advanced Systemic Mastocytosis

Phase 1

• Conditions: Advanced Systemic Mastocytosis (AdvSM); MedDRA version: 20.0Level: LLTClassification code 10056453Term: Aggressive systemic mastocytosisSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001010-10-NO
• Lead Sponsor: Cogent Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-21
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Diagnosed with 1 of the following advanced mastocytosis diagnoses by Eligibility Committee:
a. Aggressive Systemic Mastocytosis (ASM)
b. Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)
c. Mast Cell Leukemia (MCL)
2. Measurable disease according to modified IWG-MRT-ECNM criteria
3. ECOG Status 0 to 3
4. Have clinically acceptable laboratory screening results (clinical chemistry, hematology) within certain limits
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Persistent toxicity from previous therapy for Advanced Systemic Mastocytosis that has not resolved to = Grade 1
2. Associated hematologic neoplasm requiring immediate antineoplastic therapy
3. Clinically significant cardiac disease
4. Known positivity for the FIP1L1 PDGFRA fusion (patients with eosinophilia without detectable KIT D816V mutation must also lack the PDGFRA fusion mutation prior to enrolment)
5. Seropositive for human immunodeficiency virus (HIV) 1 or 2, positive for hepatitis B surface antigen, or positive for hepatitis C virus (HCV) antibody
6. History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
7. Diagnosed with or treated for malignancy other than the disease under study within the prior 3 years before enrollment
8. Received any cytoreductive therapy or any investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon, and any antibody therapy less than 28 days, before screening bone marrow biopsy
9. Received hematopoietic growth factor support within 14 days before the first dose of study drug.
10. Received strong CYP3A4 inhibitors or inducers before the first dose of study drug
11. Need for treatment with steroids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified