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

• Conditions: Systemic Mastocytoses, Indolent; Systemic Mastocytoses, Aggressive

• Registration Number: NCT06915766
• Lead Sponsor: Cogent Biosciences, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified