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NCT05152147 (Zanidatamab in 1L HER2-positive Advanced or Metastatic Gastric…): BVCT ex-ante prediction vs. reported outcome

On 19 Jan 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 17 Nov 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (superior PFS for both doublet and triplet combo therapies) and commercially sufficient (superior OS for triplet combo therapy).

Clinical Trial

NCTID
NCT05152147
Acronym
HERIZON-GEA-01
Drug Name
Zanidatamab
Drug MoA
biparatopic anti-HER2 inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
1L HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
Human Patients
920
Sponsor
Jazz Pharmaceuticals
Phase
Phase 3

Prediction of , index 590

Prospective Prediction
Prediction Index
590
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS for [zanidatamab + tislelizumab + chemotherapy] at least numerically superior to [zanidatamab + chemotherapy]; both superior to [trastuzumab + chemotherapy])
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS for [zanidatamab + tislelizumab + chemotherapy] at least numerically superior to [zanidatamab + chemotherapy]; both superior to [trastuzumab + chemotherapy])

Readout of

Prediction Validation
Readout Date
Prediction To Readout
302 days in advance
Readout Data Interpretation
zanidatamab + tislelizumab + chemotherapy achieved superiority in both PFS and OS compared with the control arm trastuzumab plus chemotherapy; whereas zanidatamab + chemotherapy achieved superiority in PFS only (not in OS) compared with the control arm trastuzumab plus chemotherapy
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (superior PFS for both doublet and triplet combo therapies) and commercially sufficient (superior OS for triplet combo therapy)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)
Phase
Phase 3
Status
Active not recruiting
Enrollment
920
Lead sponsor
Jazz Pharmaceuticals
Conditions
Gastric Neoplasms; Gastroesophageal Adenocarcinoma; Esophageal Adenocarcinoma
Interventions
DRUG: Zanidatamab; DRUG: Tislelizumab; DRUG: Trastuzumab; DRUG: Capecitabine; DRUG: Oxaliplatin; DRUG: Cisplatin; DRUG: 5-Fluorouracil
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-12-02
Primary completion
2026-07-15
Completion
2027-09-30
Primary outcomes
  • Progression-free survival (PFS) by BICR (Up to 2.5 years)
  • Overall survival (Up to 3.5 years)

NCT05152147 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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