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NCT05271604 (Ozuriftamab Vedotin PD-1 inhibitor in Head and Neck Cancer): BVCT ex-ante prediction vs. reported outcome

On 3 Sep 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 14 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet commercially insufficient.

Clinical Trial

NCTID
NCT05271604
Drug Name
Ozuriftamab Vedotin (BA3021) PD-1 inhibitor
Drug MoA
anti-ROR2 ADC
Drug Modality
antibody-drug conjugate (ADC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Head and Neck Cancer
Human Patients
80
Sponsor
BioAtla
Phase
Phase 2

Prediction of , index 1235

Prospective Prediction
Prediction Index
1235
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
254 days in advance
Readout Data Interpretation
15% ORR for SCCHN (vs 13-16% ORR by anti-PD1).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet 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 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Phase
Phase 2
Status
Completed
Enrollment
42
Lead sponsor
BioAtla, Inc.
Conditions
Head and Neck Cancer; Squamous Cell Carcinoma of Head and Neck; Recurrent Squamous Cell Carcinoma of the Head and Neck; Metastatic Cancer; Metastatic Squamous Cell Carcinoma of the Head and Neck
Interventions
BIOLOGICAL: Ozuriftamab Vedotin; BIOLOGICAL: Pembrolizumab; BIOLOGICAL: Evalstotug (BA3071); BIOLOGICAL: Cetuximab
Design
Randomized · Single group · None
Primary purpose
Treatment
Start
2022-12-13
Primary completion
2025-09-22
Completion
2025-09-22
Primary outcomes
  • Confirmed Objective Response Rate (ORR) per RECIST v1.1 (Up to 24 months)
  • Incidence of Adverse Events or Serious Adverse Events as assessed by CTCAE v5 (Up to 24 months)

NCT05271604 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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