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www.unumrx.comCogent Biosciences expects to release top-line results from the SUMMIT Part 2 trial, evaluating bezuclastinib for NonAdvSM, in July 2025.
clinical readoutThe APEX trial in AdvSM patients has completed enrollment, with top-line results anticipated in the second half of 2025, indicating progress in clinical development.
clinical readoutCogent Biosciences is set to announce top-line results from the PEAK trial in 2nd-line GIST patients by the end of 2025, highlighting ongoing clinical efforts.
clinical readoutCogent plans to submit its first New Drug Application (NDA) for bezuclastinib by the end of 2025, marking a pivotal step in its drug development pipeline.
otherCogent Biosciences is conducting a Phase 2 clinical trial of bezuclastinib (CGT9486) in patients with advanced systemic mastocytosis, including aggressive SM, SM with associated hematologic neoplasm, and mast cell leukemia. The trial, which began in November 2021 and is currently recruiting, is expected to complete by July 1, 2026. Bezuclastinib is an investigational KIT inhibitor targeting rare hematologic malignancies. Trial results may inform future regulatory and commercial decisions.
trial completionCogent Biosciences is conducting a Phase 3, randomized, open-label trial evaluating CGT9486 in combination with sunitinib versus sunitinib alone in patients with gastrointestinal stromal tumors (GIST) who are intolerant to or have failed prior imatinib treatment. The study, enrolling approximately 442 patients, is expected to complete by September 1, 2026. CGT9486 is an investigational tyrosine kinase inhibitor targeting KIT mutations, aiming to improve outcomes in GIST, a rare cancer with limited treatment options after imatinib failure.
trial completionCogent Biosciences is conducting a Phase 1/2 open-label trial of CGT4859, an FGFR2/3 inhibitor, in adults with intrahepatic cholangiocarcinoma and other advanced solid tumors harboring FGFR2 or FGFR3 alterations. The study, which began in January 2025, is expected to complete on June 1, 2027. The trial aims to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity in approximately 110 participants. CGT4859 is an investigational targeted therapy designed to inhibit FGFR2/3, which are implicated in certain cancers.
trial completionCogent Biosciences is conducting a multi-part, randomized, double-blind, placebo-controlled Phase 2 trial evaluating bezuclastinib (CGT9486) in patients with nonadvanced systemic mastocytosis, including indolent and smoldering forms. The study, which began in June 2022 and is no longer recruiting, is expected to complete by April 1, 2030. The trial compares bezuclastinib plus best supportive care to placebo, with a total enrollment of 207 patients. Bezuclastinib is an investigational KIT inhibitor targeting mast cell-driven diseases.
trial completion