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Official Title

A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Phase
Phase 2
Sponsor
Cogent Biosciences, Inc.
Enrollment
140
Timeline
Nov 2021 → Jul 2026
About This Study

This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

Eligibility Criteria

Inclusion Criteria

  • 1Diagnosed with one of the following advanced mastocytosis diagnoses by Eligibility Committee
  • 2Aggressive Systemic Mastocytosis (ASM)
  • 3Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)
  • 4Mast Cell Leukemia (MCL)
  • 5Measurable disease according to modified IWG-MRT-ECNM criteria. (A subset of patients inevaluble per mIWG-MRT-ECNM will be included in the study).
  • 6ECOG (0 to 3)
  • 7Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
  • 8Rollover Cohort
  • 9Demonstrate AHN progression requiring immediate AHN-directed therapy while receiving bezuclastinib
  • 10Demonstrated clinical benefit from bezuclastinib therapy
  • 11Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
  • 12High-Risk Cohort
  • 13Receiving or indicated for AHN-directed therapy.
  • 14Diagnosed with one of the following pathologic diagnoses of SM-AHN:
  • 15Myelodysplastic syndrome (MDS) that is high- or very high-risk
  • 16Accelerated phase myeloproliferative neoplasm (MPN)
  • 17MDS with excessive blasts in bone marrow or peripheral blood
  • 18Chronic myelomonocytic leukemia-2 (CMML-2)
  • 19Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits.

Exclusion Criteria

  • 1Persistent toxicity from previous therapy for AdvSM that has not resolved to ≤ Grade 1
  • 2Associated hematologic neoplasm requiring immediate antineoplastic therapy
  • 3Clinically significant cardiac disease
  • 4Known positivity for the FIP1L1 PDGFRA fusion. Patients with eosinophilia without detectable KIT D816V mutation must demonstrate lack of PDGFRA fusion mutation prior to enrollment
  • 5Seropositive for human immunodeficiency virus (HIV) 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody
  • 6History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
  • 7Diagnosed with or treated for malignancy other than the disease under study within the prior 3 years before enrollment
  • 8Received 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
  • 9Received hematopoietic growth factor support within 14 days before the first dose of study drug
  • 10Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives, whichever is longer, before the first dose of study drug
  • 11Need for treatment with high dose steroids
  • 12Diagnosis of Philadelphia chromosome-positive malignancy
  • 13Diagnosis of acute myeloid leukemia (AML)
  • 14Appropriate for allogenic hematopoietic stem cell transplantation
  • 15Any contraindication to selected concomitant therapy
  • 16Rollover Cohort: Have not demonstrated acceptable tolerability of previous bezuclastinib therapy
  • 17High-Risk Cohort: Previously treated with investigational therapy for AdvSM
  • 18High-Risk Cohort: Previously treated with cytoreductive therapy and discontinued due to treatment-related toxicity
  • 19High-Risk Cohort: 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 or archival bone marrow biopsy

Locations

42 sites participating in this study

Winship Cancer Institute - Emory University

Atlanta, Georgia 30322

Recruiting

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama 35233

Active, Not Recruiting

Mayo Clinic Arizona

Phoenix, Arizona 85054

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →