Trial Profile

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

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 16 Jun 2025

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At a glance

Drugs Bezuclastinib (Primary) ; Azacitidine
Indications Mast Cell Leukemia; Systemic mastocytosis
Focus Adverse reactions; Registrational; Therapeutic Use
Acronyms APEX
Sponsors Cogent Biosciences

Most Recent Events

11 Jun 2025 According to a Cogent Biosciences Media Release, company plans to report results In the second half of 2025.
12 Mar 2025 Planned primary completion date changed from 1 Jul 2025 to 1 Sep 2025.
25 Feb 2025 According to a Cogent Biosciences Media Release, positive updated data from this study was presented at the American Society of Hematology (ASH) annual meeting.

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