Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

May 21, 2026 updated by: BicycleTx Limited

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)

This is a global, multicenter, randomized, open-label study. The main objective of the study is to measure the clinical activity and safety of zelenectide pevedotin formally BT8009, in combination with pembrolizumab versus chemotherapy, and as monotherapy in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection for zelenectide pevedotin and is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
375

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Instituto Alexander Fleming
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Argentina, C1120AAT
        • Centro de Diagnostico Urologico S.R.L.
      • Buenos Aires, Argentina, C1419AHN
        • Hospital Sirio Libanes de Buenos Aires
      • Cipolletti, Argentina, R8324
        • Fundacion Medica Rio Negro y Neuquen
      • Córdoba, Argentina, X5008HHW
        • Centro Medico Privado (CEMAIC)
      • La Rioja, Argentina, 5300
        • Fundación CORI para la Investigación y Prevención del Cáncer
      • Pergamino, Argentina, B2700CPM
        • Centro de Investigacion Pergamino S.A.
      • Santa Fe, Argentina, S2000KZE
        • Instituto de Oncología de Rosario
      • Viedma, Argentina, 8500
        • Clinica Viedma S.A.
  • Australia
      • Adelaide, Australia, 5000
        • Cancer Research SA
      • Brisbane, Australia, 4101
        • Mater Misericordiae Ltd, South Brisbane
      • Douglas, Australia, QLD 4814
        • Townsville Hospital and Health Service
      • Geelong, Australia, 3220
        • Barwon Health
      • Hunter, Australia, 2310
        • Calvary Mater Newcastle
      • Nedlands, Australia, 6009
        • Sir Charles Gairdner Hospital
      • New South Wales, Australia, 2148
        • Blacktown Hospital
      • South Brisbane, Australia, 4066
        • Icon Cancer Centre
      • Southport, Australia, 4215
        • Gold Coast University Hospital
  • Belgium
      • Ghent, Belgium, 9000
        • General Hospital Maria Middelares
      • Ghent, Belgium, 9000
        • University Hospital Gent
  • Brazil
      • Barretos, Brazil, 14784-400
        • Fundacao PIO XII - Hospital de Amor
      • Florianópolis, Brazil, 88020-210
        • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
      • São Paulo, Brazil, 01327-001
        • Hospital Alemao Oswaldo Cruz
  • Canada
      • Québec, Canada, H4A 3J1
        • McGill University Health Center
      • Toronto, Canada, M5G 2M9
        • Princess Margaret Hospital
  • Chile
      • Santiago, Chile, 7500921
        • Fundación Arturo López Pérez (FALP)
      • Santiago, Chile, 8420000
        • Centro de Investigacion Clinica Bradford Hill
      • Viña del Mar, Chile, 2520598
        • Oncocentro Apys
  • France
      • Besançon, France, 25000
        • Service d'Oncologie Medicale - CHRU Besancon
      • Bordeaux, France, 33000
        • CHU Bordeaux - Hopital Saint-Andre
      • Le Mans, France, 72000
        • Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo
      • Pierre-Bénite, France, 69495
        • HCL Centre Hospitalier Lyon Sud
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Georgia
      • Batumi, Georgia, 6000
        • LTD High Technology Hospital Medcenter
      • Tbilisi, Georgia, 0141
        • The First University Clinic of Tbilisi State Medical University
      • Tbilisi, Georgia, 0159
        • New Vision University Hospital
      • Tbilisi, Georgia, 0186
        • Multiprofile Clinic Consilium Medulla LTD
  • Germany
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
  • Hungary
      • Budapest, Hungary, H-1122
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary, H-1145
        • Budapesti Uzsoki Utcai Korhaz
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9112001
        • Hadassah Hebrew University Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center - Beilinson Hospital
  • Italy
      • Aviano, Italy, 33081
        • Centro Riferimento Oncologico - Aviano
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino IRCCS
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
  • Poland
      • Gdansk, Poland, 80-210
        • Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
      • Wieliszew, Poland, 05-135
        • Mazowiecki Szpital Onkologiczny
  • Serbia
      • Belgrade, Serbia, 11000
        • University Clinical Center of Serbia, Clinic of Urology
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital
  • South Korea
      • Daejeon, South Korea, 35015
        • Chungnam national university hospital
      • Goyang, South Korea, 10408
        • National Cancer Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 3722
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Barcelona, Spain, 08026
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08908
        • Institut Català d'Oncologia - L'Hospitalet
      • Las Palmas de Gran Canaria, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
      • Madrid, Spain, 28027
        • Clínica Universidad de Navarra - Madrid
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28040
        • Hospital Fundación Jiménez Díaz
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona
      • San Sebastián, Spain, 20014
        • Hospital Universitario Donostia
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Universitario de Santiago
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital (CGMHLK)
  • Turkey (Türkiye)
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34899
        • Istinye Universitesi VM Medical Park Pendik Hastanesi
      • Izmir, Turkey (Türkiye), 35575
        • Medical Point Izmir Hospital
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli University Faculty of Medicine
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, United Kingdom, NW1 2PG
        • University College London Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami - Sylvester Comprehensive Cancer Center
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center of Florida, Inc.
      • Tampa, Florida, United States, 33612
        • Moffitt
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • UofL Health Brown Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC) - Hollings Cancer Center
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 primary 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 receiving study medications, 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cohort 1: Arm 3
Participants will receive Platinum-based combination chemotherapy +/- avelumab maintenance
Drug: Gemcitabine + cisplatin Or carboplatin
Participants will receive Gemcitabine on Days 1 and 8 of every 21-day cycle plus cisplatin Or carboplatin on Day 1 of every 21-day cycle.
Drug: Avelumab
After 4-6 cycles of Gemcitabine + Cisplatin or Carboplatin participants will receive maintenance Avelumab, if clinically indicated, on Days 1 and 15 each 28-day cycle.
Experimental: Cohort 1: Zelenectide pevedotin Arm 1
Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
Drug: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Other Names:
  • BT8009
Drug: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Other Names:
  • BT8009
Drug: Pembrolizumab
Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the zelenectide pevedotin infusion.
Experimental: Cohort 1: Zelenectide pevedotin Arm 2
Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
Drug: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Other Names:
  • BT8009
Drug: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Other Names:
  • BT8009
Drug: Pembrolizumab
Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the zelenectide pevedotin infusion.
Experimental: Cohort 2: Zelenectide pevedotin Arm 1
Participants will receive zelenectide pevedotin.
Drug: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Other Names:
  • BT8009
Drug: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Other Names:
  • BT8009
Experimental: Cohort 2: Zelenectide pevedotin Arm 2
Participants will receive zelenectide pevedotin.
Drug: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.
Other Names:
  • BT8009
Drug: Zelenectide pevedotin
Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.
Other Names:
  • BT8009

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 2: PFS per RECIST v1.1 assessed by BICR of zelenectide pevedotin monotherapy in each treatment regimen
Time Frame: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
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
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cohort 1: PFS per RECIST v1.1 assessed by BICR of zelenectide pevedotin combined treatment arms versus chemotherapy
Time Frame: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 1: ORR per RECIST v1.1 assessed by BICR of optimal dose zelenectide pevedotin in combination with pembrolizumab versus chemotherapy.
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Cohort 1: ORR per RECIST v1.1 assessed by BICR of zelenectide pevedotin combined treatment arms versus chemotherapy
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Cohort 1: Overall survival (OS) rate of optimal dose zelenectide pevedotin in combination with pembrolizumab versus chemotherapy
Time Frame: Up to approximately 4 years
The time from randomization to date of death from any cause.
Up to approximately 4 years
Cohort 1: Duration of response (DoR) per RECIST v1.1 assessed by BICR of optimal dose of zelenectide pevedotin in combination with pembrolizumab
Time Frame: Up to approximately 4 years
The time from time of first documentation of objective response that is subsequently confirmed to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 1: Disease control rate (DCR) per RECIST v1.1 assessed by BICR of optimal dose of zelenectide pevedotin in combination with pembrolizumab
Time Frame: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 1: PFS per RECIST v1.1 assessed by BICR of unselected zelenectide pevedotin dose in combination with pembrolizumab
Time Frame: Up to approximately 4 years
The time from randomization to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 1: OS rate of zelenectide pevedotin combined treatment arms in combination with pembrolizumab versus chemotherapy
Time Frame: Up to approximately 4 years
The time from randomization to date of death from any cause
Up to approximately 4 years
Cohort 2: DoR per RECIST v1.1 assessed by BICR in each treatment regimen
Time Frame: Up to approximately 4 years
The time from time of first documentation of objective response that is subsequently confirmed to date of first documentation of disease progression or death.
Up to approximately 4 years
Cohort 2: DCR per RECIST v1.1 assessed by BICR in each treatment regimen
Time Frame: Up to approximately 4 years
The time from cycle 1 Day 1 to date of first documentation of disease progression or death
Up to approximately 4 years
Cohort 2: OS rate in each treatment regimen
Time Frame: Up to approximately 4 years
The time from randomization to date of death from any cause
Up to approximately 4 years
Cohorts 1 and 2: Safety and tolerability of each treatment regimen
Time Frame: Until 30 days post last dose, up to approximately 4 years
Safety will be reported as incidence, severity, seriousness, relationship to study and types of adverse events
Until 30 days post last dose, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin area under the plasma concentration-time curve (AUC)
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin pharmacokinetic (PK) parameter (AUC) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin AUC
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (AUC) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for monomethyl auristatin (MMAE) AUC
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (AUC) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE AUC
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (AUC) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin maximum plasma concentration (Cmax)
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cmax) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin Cmax
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cmax) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cmax
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cmax
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin average plasma concentration (Cavg)
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cavg) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin Cavg
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cavg) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cavg
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and ORR.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cavg
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and PFS.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for zelenectide pevedotin AUC
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (AUC) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for MMAE AUC
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (AUC) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for zelenectide pevedotin Cmax
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cmax) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for MMAE Cmax
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for zelenectide pevedotin Cavg
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cavg) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years
Exposure-safety relationships for MMAE Cavg
Time Frame: Until the end of treatment, up to approximately 4 years
Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.
Until the end of treatment, up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BicycleTx Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BT8009-230
  • 2023-504231-41 (EudraCT Number)
  • U1111-1300-3791 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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