BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05163041 (BT7480 in Advanced Solid Tumor): BVCT ex-ante prediction vs. reported outcome

On 12 Sep 2024, BioinvestGPT's BVCT predicted technical partial success and commercial success for this trial. The 20 Mar 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant and commercially insufficient.

Clinical Trial

NCTID
NCT05163041
Drug Name
BT7480
Drug MoA
bicycle drug conjugate Nectin-4 targeted CD137 agonist
Drug Modality
bicycle conjugate
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Solid Tumor
Human Patients
200
Sponsor
BicycleTx Limited
Phase
Phase 1 Phase 2

Prediction of , index 1783

Prospective Prediction
Prediction Index
1783
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient (additive) clinical benefit in OS numerically inferior to enfortumab vedotin in 2L/3L clinical setting for nectin4overexpressing advance solid tumors that don't have FDA-approved drugs)
Technical Prediction
partial SUCCESS (statistically significant (additive) clinical benefit in ORR/PFS non-inferior non-superior to enfortumab vedotin in 2L/3L clinical setting for nectin4-overexpressing advance solid tumors)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
554 days in advance
Readout Data Interpretation
BT7480's further development has been discontinued probably due to non-superior-to-SoC clinical benefit
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
200
Lead sponsor
BicycleTx Limited
Conditions
Advanced Solid Tumor
Interventions
DRUG: BT7480; DRUG: Nivolumab
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2021-11-02
Primary completion
2026-08
Completion
2026-12
Primary outcomes
  • Number of patients with treatment emergent adverse events in dose escalation phase (From Cycle 1 Day 1 (each cycle is 28 days) until 30 (+/-5) days after the last dose of study drug)
  • Number of patients with treatment emergent adverse events in dose escalation phase (From Cycle 1 Day 1 (each cycle is 28 days) until 125 (+/-5) days after the last dose of study drug)
  • Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase (From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months)
  • Confirmed response rate as measured by clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase (From Cycle 1 Day 1 (each cycle is 28 days) through study completion, an average of 6 months)

NCT05163041 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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