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NCT04996875 (bezuclastinib in Advanced Systemic Mastocytosis): BVCT ex-ante prediction vs. reported outcome

On 14 Jan 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 8 Dec 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT04996875
Acronym
APEX
Drug Name
bezuclastinib
Drug MoA
selective KIT D816V inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Systemic Mastocytosis (AdvSM)
Human Patients
140
Sponsor
Cogent Biosciences
Phase
Phase 2

Prediction of , index 781

Prospective Prediction
Prediction Index
781
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit featuring superior-to-avapritinib efficacy in OS and superior-to-avapritinib toxicity)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS non-superior-to avapritinib)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
328 days in advance
Readout Data Interpretation
bezuclastinib achieved 57% ORR per mIWG criteria, which is non-superior to 75% ORR per mIWG criteria achieved by avapritinib; bezuclastinib achieved 0% discontinuation, which is superior to 13% discontinuation rate achieved by avapritinib (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 2
Status
Recruiting
Enrollment
140
Lead sponsor
Cogent Biosciences, Inc.
Conditions
Advanced Systemic Mastocytosis (AdvSM); SM With an Associated Hematologic Neoplasm (SM-AHN); Mast Cell Leukemia (MCL); Aggressive Systemic Mastocytosis (ASM)
Interventions
DRUG: bezuclastinib
Design
Single group · None
Primary purpose
Treatment
Start
2021-11-09
Primary completion
2025-09-19
Completion
2027-07
Primary outcomes
  • Part I: Identify clinically active and tolerable exposures of bezuclastinib in patients with AdvSM (18 months)
  • Part II: - Determine efficacy of bezuclastinib as measured by mIWG Objective Response Rate (ORR) - Confirm the exposure-response relationship of bezuclastinib (18 months)

NCT04996875 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials