Clinical trial · Expanded Access
Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
NCT06915766CI-TRIAL-00117646availableClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Systemic Mastocytoses, Aggressive | — | UNRESOLVED | — |
| Systemic Mastocytoses, Indolent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bezuclastinib | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key 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.
References
Publications (0)
Data not yet available
No reference posted for this study.