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NCT05980416 (EO-3021 in Pancreas Neoplasm Stomach Neoplasm Gastrointestinal Neoplasms…): BVCT ex-ante prediction vs. reported outcome

On 23 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 6 Aug 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (moderate ORR) and commercially insufficient.

Clinical Trial

NCTID
NCT05980416
Drug Name
EO-3021
Drug MoA
DAR-2 anti-claudin18.2 ADC with MMAE as payload
Drug Modality
antibody-drug conjugate (ADC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Pancreas Neoplasm Stomach Neoplasm Gastrointestinal Neoplasms Digestive System Neoplasm Neoplasms by Site Neoplasms
Human Patients
120
Sponsor
Elevation Oncology
Phase
Phase 1

Prediction of , index 1554

Prospective Prediction
Prediction Index
1554
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit with non-superior-to-zolbetuximab efficacy and non-superior-to-zolbetuximab toxicity)
Technical Prediction
partial SUCCESS (statistically significant yet moderate additive clinical benefit due to dose-limiting toxicity whose degree depends on claudin 18.2 expression levels)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
105 days in advance
Readout Data Interpretation
EO-3021 achieved 20% ORR which is significantly lower than 47% ORR achieved by EO-3021 in previous Chinese-only study; 42.8% ORR for CLDN18.2 > 20% and 0% ORR for Claudin 18.2 <20% Four dose-limiting toxicities at 2.9mg/kg dose.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (moderate ORR) 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 1 Dose Escalation and Expansion Study of EO-3021, an Anti-claudin 18.2 (CLDN18.2) Antibody Drug Conjugate, in Patients With Solid Tumors Likely to Express CLDN18.2
Phase
Phase 1
Status
Terminated
Enrollment
88
Lead sponsor
Elevation Oncology
Conditions
Stomach Neoplasm; Gastrointestinal Neoplasms; Digestive System Neoplasm; Neoplasms by Site; Neoplasms
Interventions
DRUG: EO-3021; DRUG: Ramucirumab (CYRAMZA®); DRUG: Dostarlimab
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2023-08-10
Primary completion
2025-05-07
Completion
2025-06-02
Results first posted
2025-11-14
Primary outcomes
  • Number of Patients With Treatment Emergent Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. (From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose))
  • The Incidence Rate of Dose Limiting Toxicities (DLT) During the First 21-day Cycle of Treatment With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. (The first 21-day treatment cycle for each patient enrolled in the Escalation Phase)
  • Number of Patients With Serious Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. (From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose))
  • Number of Patients With Clinically Significant Changes to Vital Signs When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab (From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)
  • Number of Patients With Clinically Significant Changes in Laboratory Tests When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. (From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose))

NCT05980416 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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