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NCT04452591 (CG0070 n-dodecyl-B-D-maltoside in Non-Muscle Invasive Bladder Cancer Unresponsive to…): BVCT ex-ante prediction vs. reported outcome

On 15 Apr 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 3 May 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
NCT04452591
Acronym
BOND-003
Drug Name
CG0070 n-dodecyl-B-D-maltoside
Drug MoA
oncolytic adenovirus genetically engineered with an E2F1 promoter region to replicate only in Rb-defective cells and a GM-CSF transgene
Drug Modality
oncolytic virus therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin
Human Patients
190
Sponsor
CG Oncology
Phase
Phase 3

Prediction of , index 1543

Prospective Prediction
Prediction Index
1543
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit with maybe inferior-to-pembrolizumab efficacy in CR/PFS)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
18 days in advance
Readout Data Interpretation
75.2% CR any time at month 12 (vs 100% CR any time for pembrolizumab at month 12. ASCO 19 KEYNOTE-057); no grade 3 TEAE.
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 3 Study of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)
Phase
Phase 3
Status
Active not recruiting
Enrollment
190
Lead sponsor
CG Oncology, Inc.
Conditions
Non Muscle Invasive Bladder Cancer; High-grade Ta/ T1 Papillary Disease Bladder Cancer
Interventions
BIOLOGICAL: Cretostimogene Grenadenorepvec; OTHER: n-dodecyl-B-D-maltoside
Design
Non randomized · Single group · None
Primary purpose
Treatment
Start
2020-10-27
Primary completion
2030-06-16
Completion
2031-12-24
Primary outcomes
  • Cohort C: (36 months)
  • Cohort P: (36 months)

NCT04452591 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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