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NCT06106308 (Onvansertib in KRAS/NRAS-mutant 1L mCRC): BVCT ex-ante prediction vs. reported outcome

On 24 Apr 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 29 Jul 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially TBD (wait for OS data).

Clinical Trial

NCTID
NCT06106308
Drug Name
Onvansertib
Drug MoA
PLK1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
KRAS/NRAS-mutant 1L mCRC
Human Patients
113
Sponsor
Cardiff Oncology
Phase
Phase 2

Prediction of , index 1561

Prospective Prediction
Prediction Index
1561
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS with additive toxicity)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit in ORR with additive toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
461 days in advance
Readout Data Interpretation
onvansertib 30mg + chemotherapy + bevacizumab achieved 49% cORR that’s numerically superior to 30% cORR achieved by chemotherapy + bevacizumab (no p-value provided); onvansertib 30mg + chemotherapy + bevacizumab achieved statistically insignificant mPFS improvement compared with chemotherapy + bevacizumab (no p-value provided)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant and commercially TBD (wait for OS data)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation
Phase
Phase 2
Status
Active not recruiting
Enrollment
110
Lead sponsor
Cardiff Oncology
Conditions
Metastatic Colorectal Cancer; CRC; KRAS/NRAS Mutation
Interventions
DRUG: Onvansertib; DRUG: FOLFIRI; DRUG: Bevacizumab; DRUG: FOLFOX
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2024-02-27
Primary completion
2026-11
Completion
2027-01
Primary outcomes
  • Objective Response Rate (ORR) (Up to approximately 1 year)

NCT06106308 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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