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NCT05480306 (Sirexatamab in 2L MSS Colorectal Cancer): BVCT ex-ante prediction vs. reported outcome

On 28 Apr 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 28 Jan 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant yet weak additive efficacy and commercially probably insufficient (weak additive ORR).

Clinical Trial

NCTID
NCT05480306
Acronym
DeFianCe
Drug Name
Sirexatamab (DKN-01)
Drug MoA
anti-DKK1 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
2L MSS Colorectal Cancer
Human Patients
189
Sponsor
Leap Therapeutics
Phase
Phase 2

Prediction of , index 526

Prospective Prediction
Prediction Index
526
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to SoC in OS)
Technical Prediction
FAILURE (statistically maybe significant yet very weak additive clinical benefit to SoC in PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
275 days in advance
Readout Data Interpretation
sirexatamab + bevacizumab + chemotherapy achieved a 12% delta in confirmed ORR (35% vs 23%); compared with bevacizumab + chemotherapy
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant yet weak additive efficacy and commercially probably insufficient (weak additive ORR)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Randomized Phase 2 Study of DKN-01 Plus FOLFIRI/FOLFOX and Bevacizumab Versus FOLFIRI/FOLFOX and Bevacizumab as Second-line Treatment of Advanced Colorectal Cancer (DeFianCe)
Phase
Phase 2
Status
Completed
Enrollment
188
Lead sponsor
Leap Therapeutics, Inc.
Conditions
Colorectal Cancer; Colorectal Adenocarcinoma; Colo-rectal Cancer; Colorectal Cancer Metastatic
Interventions
DRUG: DKN-01; DRUG: FOLFIRI; DRUG: Bevacizumab; DRUG: FOLFOX
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-08-30
Primary completion
2025-07-10
Completion
2025-07-10
Primary outcomes
  • Progression Free Survival (PFS) (approximately 6 months)

NCT05480306 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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