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NCT04561362 (BT8009 in metastatic urothelial cancer): 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 14 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (numerically inferior to enfortumab vedotin) and commercially TBD.

Clinical Trial

NCTID
NCT04561362
Acronym
Duravelo-1
Drug Name
BT8009
Drug MoA
anti-nectin4 BTC with MMAE payload
Drug Modality
bicycle toxin conjugate
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
metastatic urothelial cancer
Human Patients
329
Sponsor
Bicycle Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1784

Prospective Prediction
Prediction Index
1784
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient (additive) clinical benefit in OS non-inferior-non-superior to enfortumab vedotin in 2L/3L clinical setting for nectin4-overexpressing advance solid tumors that don’t have FDA-approved drugs)
Technical Prediction
partial SUCCESS (statistically significant (additive) clinical benefit in ORR/PFS numerically inferior to enfortumab vedotin in 2L/3L clinical setting for nectin4-overexpressing advance solid tumors)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
2 days in advance
Readout Data Interpretation
BT8009 achieved 36.8% cORR (14/38); lower than enfortumab vedotin 40.6% cORR (NEJM DOI- 10.1056/NEJMoa2035807).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (numerically inferior to enfortumab vedotin) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
329
Lead sponsor
BicycleTx Limited
Conditions
Urinary Bladder Neoplasm; Triple Negative Breast Neoplasms; Hormone Receptor Positive, HER2-negative Neoplasms; Hormone Receptor Positive, HER2-low Neoplasms; Breast Neoplasms; Non-Small-Cell Lung Neoplasms; Ovarian Neoplasm; Advanced Solid Tumor
Interventions
DRUG: BT8009; DRUG: Pembrolizumab
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2020-07-17
Primary completion
2026-03
Completion
2026-12
Primary outcomes
  • Parts A-1, A-2 and C: Number of participants with treatment emergent adverse events, receiving BT8009 as a monotherapy or in combination with pembrolizumab to assess safety and tolerability. (From cycle 1 day 1 until 30 days after the end of treatment or approximately 1 year)
  • Parts A-1 and A-2 (escalations): Number of participants with dose limiting toxicities on BT8009 as a monotherapy or in combination with pembrolizumab (28 days (for cycles that are either 21 or 28 days in length depending on dosing schedule assigned))
  • Part B1-B7: Objective response rate (ORR) to assess the clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab using RECIST 1.1. (Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or, death, or up to three years)
  • Part D: Maximum plasma concentration (Cmax) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy (From Cycle 1 Day 1 through end of treatment or for up to 1 year)
  • Part D: Minimum plasma concentration (Cmin) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy (From Cycle 1 Day 1 through end of treatment or for up to 1 year)

NCT04561362 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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