Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis

Sponsor: Cogent Biosciences, Inc.

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT06915766

This expanded access program provides bezuclastinib tablets to patients with systemic mastocytosis who have not responded to or cannot tolerate standard therapies. Eligible participants must be 18 or older, able to swallow tablets, and have a diagnosis per the 2022 WHO Classification. They must also provide informed consent and have acceptable lab results.

Patient Parameters

Program Overview

The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.

Eligibility Criteria

Inclusion Criteria

  • Able to provide written informed consent and commit to EAP assessments.
  • ≥18 years of age.
  • Able to swallow tablets.
  • Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM
  • Not receiving adequate disease control on current therapy(ies).
  • Have clinically acceptable laboratory screening results.

Exclusion Criteria

  • Patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical trial.
  • Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent.
  • Pregnant or currently breastfeeding.
  • Prior or ongoing clinically significant illness or medical or physical condition

Other protocol-defined criteria apply.

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