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NCT06555263 (Luveltamab Tazevibulin in Advanced or Metastatic Non-small Cell Lung…): BVCT ex-ante prediction vs. reported outcome

On 9 Nov 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 13 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially probably insufficient.

Clinical Trial

Acronym
REFRaME-L1
Drug Name
Luveltamab Tazevibulin
Drug MoA
anti-FOLR1 ADC conjugated with SC209 payload
Drug Modality
antibody-drug conjugate (ADC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Human Patients
43
Sponsor
Sutro Biopharma
Phase
Phase 2

Prediction of , index 1836

Prospective Prediction
Prediction Index
1836
Prediction Date
Commercial Prediction
FAILURE (commercially sufficient clinical benefit in OS inferior to SoC)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
124 days in advance
Readout Data Interpretation
luvelta’s further development has been discontinued due to insufficient benefit-risk profile
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant and commercially probably 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 Evaluating STRO-002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects With Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Expressing FOLR1
Phase
Phase 2
Status
Withdrawn
Enrollment
0
Lead sponsor
Sutro Biopharma, Inc.
Conditions
Lung Cancer; Lung Cancer Metastatic; Lung Cancer, Nonsmall Cell; Lung Cancer Non-Small Cell Stage IIIB; Lung Cancer Non-small Cell Stage IV; Lung Cancer, Non-small Cell
Interventions
DRUG: Luveltamab tazevibulin
Design
Single group · None
Primary purpose
Treatment
Start
2024-08-21
Primary completion
2025-05-01
Completion
2025-05-01
Primary outcomes
  • Objective Response Rate (ORR) (up to 24 months)

NCT06555263 on ClinicalTrials.gov

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