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NCT03816163 (Zolbetuximab in 1L metastatic pancreatic adenocarcinoma): BVCT ex-ante prediction vs. reported outcome

On 3 Dec 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 14 Oct 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
NCT03816163
Acronym
GLEAM
Drug Name
Zolbetuximab (IMAB362)
Drug MoA
anti-CLDN18.2 inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
1L metastatic pancreatic adenocarcinoma (PDAC)
Human Patients
393
Sponsor
Astellas Pharma
Phase
Phase 2

Prediction of , index 1849

Prospective Prediction
Prediction Index
1849
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS non-superior to SoC alone)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in ORR/PFS due to dose-limiting toxicity whose degree depends on claudin 18.2 expression levels)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
315 days in advance
Readout Data Interpretation
zolbetuximab + gemcitabine plus nab-paclitaxel failed to achieve superiority in OS compared with zolbetuximab + gemcitabine plus nab-paclitaxel alone
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, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Phase
Phase 2
Status
Active not recruiting
Enrollment
393
Lead sponsor
Astellas Pharma Global Development, Inc.
Conditions
Pancreatic Cancer; Metastatic Pancreatic Cancer; Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG: zolbetuximab; DRUG: nab-paclitaxel; DRUG: gemcitabine
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2019-03-15
Primary completion
2026-08-31
Completion
2026-08-31
Primary outcomes
  • Dose Limiting Toxicities (DLT) - (safety lead in) (Up to 28 days)
  • Overall Survival (OS) (Up to 79 months)
  • Safety assessed by Adverse Events (AEs) (From signing inform consent form until 90 days after the last dose of the study drug (Up to 82 months))
  • Safety assessed by incidence of serious adverse events (SAE) (From signing inform consent form until 90 days after the last dose of the study drug (Up to 82 months))
  • Safety assessed by incidence of treatment emergent adverse events (TEAE) (From first dose up to 30 days after last dose (Up to 80 months))

NCT03816163 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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