BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05329766 (Domvanalimab in Gastrointestinal Tract Malignancies): BVCT ex-ante prediction vs. reported outcome

On 13 May 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 12 Dec 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
NCT05329766
Acronym
EDGE-Gastric
Drug Name
Domvanalimab
Drug MoA
anti-TIGIT
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Gastrointestinal Tract Malignancies
Human Patients
332
Sponsor
Arcus Biosciences
Phase
Phase 2

Prediction of , index 509

Prospective Prediction
Prediction Index
509
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS for domvanalimab + zimberelimab + chemotherapy non-superior to 1L SoC and for domvanalimab + zimberelimab non-superior to 2L SoC)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in ORR/PFS for domvanalimab + zimberelimab + chemotherapy slightly superior to 1L SoC with moderate toxicity) partial FAILURE (statistically significant yet moderate clinical benefit in ORR/PFS for domvanalimab + zimberelimab non-superior 2L SoC)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
213 days in advance
Readout Data Interpretation
domvanalimab + zimberelimab + chemotherapy was discontinued due to futility
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 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)
Phase
Phase 2
Status
Active not recruiting
Enrollment
332
Lead sponsor
Arcus Biosciences, Inc.
Conditions
Gastrointestinal Tract Malignancies
Interventions
DRUG: Domvanalimab; DRUG: Quemliclustat; DRUG: Zimberelimab; DRUG: Fluorouracil; DRUG: Leucovorin; DRUG: Oxaliplatin
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-06-10
Primary completion
2027-01
Completion
2027-06
Primary outcomes
  • Number of Participants with Adverse Events (AEs) (Up to 18 months)
  • Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Up to 18 months)

NCT05329766 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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