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NCT05524545 (Evorpacept Enfortumab Vedotin in Urothelial Carcinoma): BVCT ex-ante prediction vs. reported outcome

On 22 Jul 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 2 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05524545
Acronym
ASPEN-07
Drug Name
Evorpacept (ALX148) Enfortumab Vedotin
Drug MoA
anti-CD47 blocker
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Urothelial Carcinoma
Human Patients
30
Sponsor
ALX Oncology
Phase
Phase 1

Prediction of , index 1094

Prospective Prediction
Prediction Index
1094
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
316 days in advance
Readout Data Interpretation
50% ORR (20 patients receiving treatments) vs. 64.5% ORR for pembrolizumab + enfortumab).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant 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, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)
Phase
Phase 1
Status
Completed
Enrollment
36
Lead sponsor
ALX Oncology Inc.
Conditions
Bladder Cancer; Urothelial Carcinoma
Interventions
DRUG: Evorpacept; DRUG: Enfortumab Vedotin
Design
Single group · None
Primary purpose
Treatment
Start
2022-11-02
Primary completion
2025-06-27
Completion
2025-06-27
Primary outcomes
  • First Cycle Dose limiting toxicities (DLTs) (Up to 28 days)
  • Adverse Events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0)), timing, seriousness, and relationship to study therapy (Up to 24 months)
  • Phase 1: Recommended Phase 2 Dose (RP2D) (Up to 15 months)

NCT05524545 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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