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NCT05208047 (Bezuclastinib in Gastrointestinal Stromal Tumors (GIST): BVCT ex-ante prediction vs. reported outcome

On 13 Oct 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 10 Nov 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (ORR/PFS) and commercially TBD.

Clinical Trial

NCTID
NCT05208047
Acronym
PEAK
Drug Name
Bezuclastinib
Drug MoA
TKI inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Gastrointestinal Stromal Tumors (GIST
Human Patients
442
Sponsor
Cogent Biosciences
Phase
Phase 3

Prediction of , index 782

Prospective Prediction
Prediction Index
782
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
759 days in advance
Readout Data Interpretation
bezuclastinib + sunitinib achieved 16.5 months mPFS vs 9.2 months mPFS achieved by sunitinib mono therapy (HR= 0.50 p<0.0001); bezuclastinib+sunitinib achieved 46% ORR vs 26% ORR achieved by sunitinib mono therapy (p<0.0001); wait for OS data
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (ORR/PFS) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
Phase
Phase 3
Status
Recruiting
Enrollment
482
Lead sponsor
Cogent Biosciences, Inc.
Conditions
Advanced Gastrointestinal Stromal Tumors; Metastatic Cancer
Interventions
DRUG: CGT9486; DRUG: CGT9486; DRUG: Sunitinib; DRUG: Sunitinib; DRUG: Midazolam; DRUG: CGT9486; DRUG: Sunitinib; DRUG: CGT9486; DRUG: Sunitinib
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-04-14
Primary completion
2025-09-30
Completion
2030-01
Primary outcomes
  • Part 1a - pharmacokinetics - Cmax (16 days)
  • Part 1a - pharmacokinetics - AUC (16 days)
  • Part 1b - pharmacokinetics - Cmax (14 days)
  • Part 1b - pharmacokinetics - AUC (14 days)
  • Part 1b - pharmacokinetics - Tmax (14 days)

NCT05208047 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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