BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05425940 (Zanzalintinib in 2L MSI-high Metastatic Colorectal Cancer): BVCT ex-ante prediction vs. reported outcome

On 7 May 2025, BioinvestGPT's BVCT predicted technical partial failure and commercial failure for this trial. The 20 Oct 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: partially statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05425940
Acronym
STELLAR-303
Drug Name
Zanzalintinib
Drug MoA
multi-receptor TKI
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
2L MSI-high Metastatic Colorectal Cancer
Human Patients
901
Sponsor
Exelixis
Phase
Phase 3

Prediction of , index 2011

Prospective Prediction
Prediction Index
2011
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit for XL092 + atezolizumab in OS non-superior to regorafenib)
Technical Prediction
partial FAILURE (statistically maybe significant yet very weak clinical benefit for XL092 + atezolizumab in ORR/PFS at most numerically superior to regorafenib)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
166 days in advance
Readout Data Interpretation
zanzalintinib + atezolizumab achieved statistically significant yet very weak OS in the ITT population (HR = 0.8 p=0.0045) yet statistically insignificant OS in the subset of patients without liver metastases (p = 0.087); compared with the regorafenib mono therapy
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
partially statistically significant 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 Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
Phase
Phase 3
Status
Active not recruiting
Enrollment
901
Lead sponsor
Exelixis
Conditions
Colorectal Cancer
Interventions
DRUG: XL092; DRUG: Atezolizumab; DRUG: Regorafenib
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-09-07
Primary completion
2026-06-16
Completion
2027-01-31
Primary outcomes
  • Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants (Up to 32 months)
  • Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in Randomized Non-Liver Metastases (NLM) Participants (Up to 32 months)

NCT05425940 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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