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NCT06225596 (zelenectide pevedotin in Metastatic Urothelial Cancer): BVCT ex-ante prediction vs. reported outcome

On 12 Sep 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 17 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
NCT06225596
Acronym
Duravelo-2
Drug Name
zelenectide pevedotin (BT8009)
Drug MoA
bicycle drug conjugate Nectin-4 targeted bicycle toxin conjugate (MMAE) Zelenectide pevedotin
Drug Modality
bicycle conjugate
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic Urothelial Cancer
Human Patients
375
Sponsor
BicycleTx Limited
Phase
Phase 2 Phase 3

Prediction of , index 1785

Prospective Prediction
Prediction Index
1785
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient (additive) clinical benefit in OS superior to chemotherapy + avelumab yet non-inferior-non-superior to enfortumab vedotin in 1L/2L clinical setting)
Technical Prediction
partial SUCCESS (statistically significant (additive) clinical benefit in ORR/PFS superior to chemotherapy + avelumab yet numerically inferior to enfortumab vedotin + pembrolizumab in 1L/2L clinical setting)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
551 days in advance
Readout Data Interpretation
BT8009's further development has been deprioritised 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
A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Phase
Phase 2
Status
Active not recruiting
Enrollment
375
Lead sponsor
BicycleTx Limited
Conditions
Metastatic Urothelial Cancer
Interventions
DRUG: Zelenectide pevedotin; DRUG: Zelenectide pevedotin; DRUG: Pembrolizumab; DRUG: Gemcitabine + cisplatin Or carboplatin; DRUG: Avelumab
Design
Randomized · Sequential · None
Primary purpose
Treatment
Start
2024-01-24
Primary completion
2028-03
Completion
2028-03
Primary outcomes
  • Cohort 1: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1(RECIST v1.1) by blinded central independent review (BICR) of optimal dose zelenectide pevedotin with pembrolizumab versus chemotherapy (Up to approximately 4 years)
  • Cohort 2: PFS per RECIST v1.1 assessed by BICR of zelenectide pevedotin monotherapy in each treatment regimen (Up to approximately 4 years)
  • Cohort 2: Objective response rate (ORR) per RECIST v1.1 assessed by BICR of zelenectide pevedotin monotherapy in each treatment regimen (Up to approximately 4 years)

NCT06225596 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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