BioinvestGPT

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NCT05252416 (BLU-222 Carboplatin Ribociclib Fulvestrant in Advanced Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 28 Apr 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 23 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially inferior to SoC.

Clinical Trial

NCTID
NCT05252416
Acronym
VELA
Drug Name
BLU-222 Carboplatin Ribociclib Fulvestrant
Drug MoA
CDK2 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Solid Tumors
Human Patients
366
Sponsor
Blueprint Medicines
Phase
Phase 1 Phase 2

Prediction of , index 1025

Prospective Prediction
Prediction Index
1025
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit as monotherapy or combotherapy)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
391 days in advance
Readout Data Interpretation
<5% ORR (unconfirmed) vs 22-23% ORR for SoC (16% ORR for chemo & 37-55% ORR enhertu).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially inferior to SoC
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients With Advanced Solid Tumors
Phase
Phase 1
Status
Terminated
Enrollment
50
Lead sponsor
Blueprint Medicines Corporation
Conditions
Advanced Solid Tumors; HR+ Breast Cancer; CCNE1 Amplification; HER2-negative Breast Cancer; Ovarian Cancer; Endometrial Cancer; Gastric Cancer; Esophageal Adenocarcinoma; Carcinosarcoma
Interventions
DRUG: BLU-222; DRUG: Carboplatin; DRUG: Ribociclib; DRUG: Fulvestrant
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-04-07
Primary completion
2025-07-04
Completion
2025-07-04
Primary outcomes
  • [Phase 1] Determine the maximum tolerated dose (MTD) of BLU-222 (Approximately 21 months)
  • [Phase 1] Determine the recommended Phase 2 dose (RP2D) of BLU-222 (Approximately 21 months)
  • [Phase 1] Rate and severity of adverse events (Approximately 21 months)
  • [Phase 2] Overall response rate (ORR) (Approximately 43 months)
  • [Phase 2] Rate and severity of adverse events (Approximately 43 months)

NCT05252416 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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