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NCT05983367 (Ompenaclid in 2L RAS-mutant Metastatic Colorectal Cancer): BVCT ex-ante prediction vs. reported outcome

On 8 May 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 7 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05983367
Drug Name
Ompenaclid
Drug MoA
SLC6A8 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
2L RAS-mutant Metastatic Colorectal Cancer (mCRC)
Human Patients
70
Sponsor
Merck KGaA
Phase
Phase 2

Prediction of , index 1586

Prospective Prediction
Prediction Index
1586
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to bevacizumab + chemotherapy in OS)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit to bevacizumab + chemotherapy in ORR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
303 days in advance
Readout Data Interpretation
ompenaclid received negative topline data and discontinued further development
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized Phase 2 Study of Ompenaclid Versus Placebo in Combination With FOLFIRI Plus Bevacizumab in Patients With Previously Treated RAS Mutant Advanced or Metastatic Colorectal Cancer
Phase
Phase 2
Status
Terminated
Enrollment
76
Lead sponsor
Inspirna, Inc.
Conditions
Colorectal Cancer; Metastatic Colon Cancer
Interventions
DRUG: Ompenaclid; DRUG: Placebo; DRUG: Bevacizumab; DRUG: FOLFIRI regimen
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-10-10
Primary completion
2025-01-31
Completion
2025-03-31
Results first posted
2026-02-20
Primary outcomes
  • Objective Response Rate (From randomization until development of radiographic disease progression (up to approximately 12 months).)

NCT05983367 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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