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NCT05186753 (Bezuclastinib in Indolent or Smoldering 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 7 Jul 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (TSS/MS2D2) and commercially TBD (wait for OS data).

Clinical Trial

NCTID
NCT05186753
Acronym
SUMMIT
Drug Name
Bezuclastinib
Drug MoA
cKIT D816V-mutation inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Indolent or Smoldering Systemic Mastocytosis
Human Patients
237
Sponsor
Cogent Biosciences
Phase
Phase 2

Prediction of , index 780

Prospective Prediction
Prediction Index
780
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit featuring superior-to-avapritinib efficacy in OS and superior-to-avapritinib toxicity)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in MS2D2 non-superior-to avapritinib)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
174 days in advance
Readout Data Interpretation
bezuclastinib achieved placebo-adjusted -8.9 point in TSS/MS2D2 at week 24 (-24.3 bezuclastinib vs -15.4 placebo; 58% improvement over placebo; p= 0.0002); numerically superior to avapritinib’s placebo-adjusted -6.4 point in TSS/MS2D2 at week 24 (-15.6 avapritinib vs -9.2 placebo; 70% improvement over placebo; p < 0.003) (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (TSS/MS2D2) and commercially TBD (wait for OS data)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 in Subjects With Nonadvanced Systemic Mastocytosis
Phase
Phase 2
Status
Active not recruiting
Enrollment
237
Lead sponsor
Cogent Biosciences, Inc.
Conditions
SSM; Mastocytosis, Indolent; Mastocytosis, Systemic; Mastocytosis; ISM; BMM; Smoldering Systemic Mastocytosis; Bone Marrow Mastocytosis
Interventions
DRUG: Bezuclastinib Tablets (Formulation A); DRUG: Bezuclastinib Tablets (Formulation B); DRUG: Placebo Tablets
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-06-27
Primary completion
2025-05-22
Completion
2030-04
Primary outcomes
  • Part 1: Determine recommended dose of bezuclastinib (CGT9486) in subjects with NonAdvSM (3 months)
  • Part 2: Efficacy of bezuclastinib at the selected dose versus placebo (24 Weeks)
  • Part 3: Safety and tolerability of bezuclastinib as assessed by number of adverse events (Up to 5 years)

NCT05186753 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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