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No longer recruiting (closed or complete)Last updated: 7 April 2026

Duravelo-2: The objective of this study is to measure how safe and effective a drug called zelenectide pevedotin is when given by itself, and in combination with immunotherapy, in people with locally advanced or metastatic urothelial cancerA Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

Duravelo-2

Clinical summary

Summary

Zelenectide pevedotin (also known as BT8009) is a Nectin-4 targeting bicycle toxin conjugate (BTC). BTCs are a new class of molecules for targeted delivery of toxins into cancer tumours. This study will evaluate BT8009 by itself and in combination with pembrolizumab immunotherapy in people with advanced or metastatic urothelial cancer (UC).

This study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts.

Cohort 1 will include participants who have not received any prior systemic therpay for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy. These participants will be randomly allocated to one of three treatments arms.

  • Arm 1: Participants will receive BT8009 on Days 1, 8 and 15, and a standard dose of pembrolizumab on Day 1 of every 21-day cycle.
  • Arm 2: Participants will receive BT8009 on Days 1 and 8, and a standard dose of pembrolizumab on Day 1 of every 21-day cycle.
  • Arm 3: Participants will receive platinum-based combination chemotherapy (gemcitabine + cisplatin or carboplatin), with or without avelumab immunotherapy maintenance.

Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC. These participants will be randomly allocated to one of three treatment arms.

  • Arm 1: Participants will receive BT8009 on Days 1, 8 and 15 of every 21-day cycle.
  • Arm 2: Participants will receive BT8009 on Days 1 and 8 of every 21-day cycle.
  • Arm 3: Participants will receive BT8009 on days 1, 8 +/- 15 and a standard dose of pembrolizumab on Day 1 of every 21-day cycle.

 

Conditions

This trial is treating people with advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra

Eligibility

Inclusion

  • 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.

Exclusion

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT06225596 *
  • BT8009-230; 2023-504231-41; U1111-1300-3791

Trial sponsor

BicycleTx Limited

Scientific 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

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