BioinvestGPT ApS · Research use only

NCT05002127 (Evorpacept in Advanced HER2+ Gastric Cancer): BVCT ex-ante prediction vs. reported outcome

On 25 Jun 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 31 Jul 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

Acronym
ASPEN-06
Drug Name
Evorpacept (ALX148)
Drug MoA
anti-CD47 blocker
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced HER2+ Gastric Cancer
Human Patients
450
Sponsor
ALX Oncology
Phase
Phase 2 Phase 3

Prediction of , index 1095

Prospective Prediction
Prediction Index
1095
Prediction Date
Commercial Prediction
SUCCESS (statistically significant additive clinical benefit to trastuzumab + ramucirumab + paclitaxel in OS as 2L/3L treatments for advanced HER2-overexpressing gastric cancer for phase 3)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit to trastuzumab + ramucirumab + paclitaxel in ORR as 2L/3L treatments for advanced HER2-overexpressing gastric cancer for phase 2)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
36 days in advance
Readout Data Interpretation
evorpacept+TRP achieved an ORR of 40.3% vs 26.6% achieved by TRP (a 13.7% delta which is lower than 30% delta at interim).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
Phase
Phase 2, Phase 3
Status
Active not recruiting
Enrollment
127
Lead sponsor
ALX Oncology Inc.
Conditions
Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma
Interventions
DRUG: Evorpacept (ALX148); DRUG: Trastuzumab; DRUG: Ramucirumab; DRUG: Paclitaxel
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-01-15
Primary completion
2024-05-24
Completion
2026-06
Primary outcomes
  • Phase 2 (Last randomized patient on study at least 16 weeks)
  • Phase 3 (From the date of randomization to the date of death (due to any cause), up to 36 months postdose)

NCT05002127 on ClinicalTrials.gov

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