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(Apex) CGT9486 in Patients With Advanced Systemic Mastocytosis

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04996875
Protocol IDs
CGT9486-20-201 (primary)
2021-001010-10
NCI-2021-09477
Study Sponsor
Cogent Biosciences, Inc.

Summary

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

  1. Diagnosed with 1 of the following advanced mastocytosis diagnoses by Eligibility Committee:
  2. Aggressive Systemic Mastocytosis (ASM)
  3. Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)
  4. Mast Cell Leukemia (MCL)
  5. Measurable disease according to modified IWG-MRT-ECNM criteria
  6. ECOG (0 to 3)
  7. Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
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