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NCT04675294 (Evorpacept in Advanced Head and Neck Squamous Cell…): BVCT ex-ante prediction vs. reported outcome

On 25 Jun 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 25 Apr 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
NCT04675294
Acronym
ASPEN-03
Drug Name
Evorpacept (ALX148)
Drug MoA
CD47 blocker
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Human Patients
189
Sponsor
ALX Oncology
Phase
Phase 2

Prediction of , index 1093

Prospective Prediction
Prediction Index
1093
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit as 1L treatment in 12-month OS non-superior to pembrolizumab + chemotherapy)
Technical Prediction
FAILURE (statistically insignificant clinical benefit as 1L treatment in ORR non-superior to pembrolizumab + chemotherapy)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
304 days in advance
Readout Data Interpretation
evorpacept + SoC failed to achieve statistically significant clinical benefit in ORR/PFS/OS compared with SoC 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 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Phase
Phase 2
Status
Active not recruiting
Enrollment
189
Lead sponsor
ALX Oncology Inc.
Conditions
Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma
Interventions
DRUG: evorpacept; DRUG: pembrolizumab
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-04-02
Primary completion
2025-03-03
Completion
2026-06-30
Primary outcomes
  • Objective response rate per RECIST 1.1 (Last randomized patient reaching at least 24 weeks of follow-up)

NCT04675294 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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