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Evaluating BT8009 for advanced bladder cancer treatment

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)

Phase2; Phase3 Interventional BicycleTx Limited · NCT06225596

This study is testing a new treatment called BT8009, alone and with another drug, to see if it can help people with advanced bladder cancer feel better and improve their outcomes.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment956 (estimated)
Ages18 Years and up
SexAll
SponsorBicycleTx Limited Industry-sponsored
Drugs / interventionsenfortumab, chemotherapy, immunotherapy, prednisone, pembrolizumab
Locations170 sites (Little Rock, Arkansas and 169 other locations)
Trial IDNCT06225596 on ClinicalTrials.gov

What this trial studies

This global, multicenter, randomized, open-label study aims to assess the efficacy and safety of BT8009, both as a standalone treatment and in combination with pembrolizumab, for patients with locally advanced or metastatic urothelial cancer. The study features an adaptive design and includes two cohorts: one for patients who have not received prior systemic therapy and are eligible for platinum-based chemotherapy, and another for those who have undergone at least one prior systemic therapy. Participants will be monitored for treatment response and safety outcomes throughout the study.

Who should consider this trial

Good fit: Ideal candidates include individuals with locally advanced or metastatic urothelial cancer who meet specific eligibility criteria and have not received prior systemic therapy or have received at least one prior treatment.

Not a fit: Patients with non-metastatic urothelial cancer or those who have already received multiple lines of systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced bladder cancer.

How similar studies have performed: Previous studies have shown promise with similar approaches in treating urothelial cancer, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Life expectancy ≥ 12 weeks.
* Measurable disease as defined by RECIST v1.1.
* Histologically or cytologically confirmed locally advanced (unresectable) or metastatic UC of the renal pelvis, ureter, bladder, or urethra.
* Archival or fresh tumor tissue comprising muscle-invasive UC or locally advanced or metastatic UC should be available for submission to central laboratory.
* Negative pregnancy test for women of childbearing potential (WOCBP) (negative serum test at Screening and negative urine or serum test within 72 hours prior to the first dose).
* Cohort 1: Previously Untreated: Eligible to receive platinum-based chemotherapy (either cisplatin- or carboplatin-based chemotherapy based on Investigator decision.
* Cohort 1: Participants must not have received prior systemic therapy for locally advanced or metastatic UC with the following exceptions:

  1. Prior local intravesical chemotherapy, local surgery when full resection is not achieved, local immunotherapy, and radiotherapy are permitted if completed at least 4 weeks prior to the initiation of study treatment and all acute toxicities have resolved.
  2. Prior neoadjuvant/adjuvant chemotherapy or monomethyl auristatin E (MMAE)-based therapy with recurrence \>12 months from completion of therapy.
  3. Prior neoadjuvant/adjuvant immune checkpoint inhibitor therapy with recurrence \>12 months from completion of therapy.
* Cohort 2: Previously Treated: Participants must have received ≥ 1 prior systemic treatment for locally advanced or metastatic UC. This includes neoadjuvant/adjuvant platinum-based chemotherapy if recurrence occurred within 12 months of completing therapy.
* Cohort 2: Progression or recurrence of UC during or following receipt of most recent therapy.

Key Exclusion Criteria:

* Active keratitis or corneal ulcerations.
* Requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A (CYP3A) or inhibitors of P-glycoprotein (P-gp) including herbal- or food-based inhibitors.
* Any condition requiring current treatment with high dose corticosteroids (\> 10 mg daily prednisone or equivalent).
* Known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to MMAE.
* Has not adequately recovered from recent major surgery (excluding placement of vascular access).
* Receipt of live or attenuated vaccine within 30 days of first dose.
* Cohort 1: Previously Untreated: Prior treatment with a checkpoint inhibitor (CPI) for any other malignancy within the last 12 months.
* Cohort 2: Previously Treated: Received more than 1 prior platinum-based chemotherapy regimen for locally advanced or metastatic UC. This includes neoadjuvant/adjuvant platinum-based chemotherapy if recurrence occurred within 12 months of completing therapy.
* Cohort 2: Prior treatment with enfortumab vedotin or any other MMAE-based therapy

Where this trial is running

Little Rock, Arkansas and 169 other locations

+120 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Urothelial CancerBT8009Bladder cancerPembrolizumabChemotherapyAvelumabZelenectide pevedotin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.