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NCT04363801 (Sirexatamab in Gastric or Gastroesophageal 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 insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04363801
Acronym
DisTinGuish
Drug Name
Sirexatamab (DKN-01)
Drug MoA
anti-DKK1 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Gastric or Gastroesophageal Cancer
Human Patients
232
Sponsor
Leap Therapeutics
Phase
Phase 2

Prediction of , index 525

Prospective Prediction
Prediction Index
525
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 + tislelizumab + chemotherapy achieved a 3% delta in confirmed ORR (52% vs 49% in average) and -2.5 months delta in PFS (8.69 months in average vs 11.2 months in average) compared with tislelizumab + chemotherapy (though the median PFS for tislelizumab plus chemotherapy in the Phase 3 Rationale-305 study was 6.9 months (95% CI- 5.7; 7.2); further developments discontinued due to weak efficacy
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 Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients With Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)
Phase
Phase 2
Status
Terminated
Enrollment
247
Lead sponsor
Leap Therapeutics, Inc.
Conditions
Gastric Cancer; Gastric Adenocarcinoma; GastroEsophageal Cancer
Interventions
DRUG: DKN-01 300mg; DRUG: DKN-01 600mg; DRUG: DKN-01 400mg; DRUG: Tislelizumab 200mg; DRUG: Tislelizumab 400mg; DRUG: Oxaliplatin; DRUG: Capecitabine 1000mg/ m2 twice daily (BID); DRUG: Leucovorin Calcium; DRUG: Fluorouracil
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2020-07-29
Primary completion
2025-03-31
Completion
2025-03-31
Results first posted
2025-10-09
Primary outcomes
  • Part A and B: Safety and Tolerability of DKN-01 in G/GEJ Patients (approximately 28 months)
  • Part C: Progression Free Survival (PFS) in G/GEJ DKK1 High and Overall Patients Treated With DKN-01 in Combination With Tislelizumab and Chemotherapy vs Tislelizumab and Chemotherapy as a First-line Therapy (approximately 30 months)

NCT04363801 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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