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NCT05483868 (Belzupacap Sarotalocan in Bladder Cancer): BVCT ex-ante prediction vs. reported outcome

On 20 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 17 Oct 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (weak clinical benefit).

Clinical Trial

NCTID
NCT05483868
Drug Name
Belzupacap Sarotalocan (AU-011)
Drug MoA
HPV nanoparticles conjugated with infrared-activated IR700 as a photodynamic therapy
Drug Modality
conjugate
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Bladder Cancer
Human Patients
21
Sponsor
Aura Biosciences
Phase
Phase 1

Prediction of , index 1551

Prospective Prediction
Prediction Index
1551
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit for AU011 with inferior-to-pembrolizumab/tebentafusp-monotherapy efficacy in OS)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in ORR/CR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
180 days in advance
Readout Data Interpretation
Bel-sar achieved 50% CR (4/8); inferior to pembrolizumab's 100% CR at any time (ASCO 19 KEYNOTE-057)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (weak clinical benefit)
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 Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer
Phase
Phase 1
Status
Active not recruiting
Enrollment
55
Lead sponsor
Aura Biosciences
Conditions
Non-muscle-invasive Bladder Cancer; NMIBC; Non-Muscle Invasive Bladder Carcinoma; Non-Muscle Invasive Bladder Neoplasms; Non-Muscle Invasive Bladder Urothelial Carcinoma; Urothelial Carcinoma Bladder
Interventions
DRUG: AU-011; COMBINATION_PRODUCT: AU-011 in Combination with Medical Laser Adminstration; COMBINATION_PRODUCT: AU-011 in Combination with Medical Laser Administration
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-09-26
Primary completion
2027-03
Completion
2027-03
Primary outcomes
  • Safety of AU-011: Incidences of SAEs and DLTs (up to 12 months)

NCT05483868 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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