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NCT06225596

PHASE2

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

Sponsor: BicycleTx Limited

View on ClinicalTrials.gov

Summary

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

375

Start Date

2024-01-24

Completion Date

2028-03

Last Updated

2026-05-27

Healthy Volunteers

Conditions

Metastatic Urothelial Cancer

Interventions

DRUG

Zelenectide pevedotin

Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.

DRUG

Zelenectide pevedotin

Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.

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.

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.

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

Locations (102)

Rocky Mountain Cancer Center

Denver, Colorado, United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Mount Sinai Medical Center of Florida, Inc.

Miami Beach, Florida, United States

Moffitt

Tampa, Florida, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

UofL Health Brown Cancer Center

Louisville, Kentucky, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Montefiore Medical Center

The Bronx, New York, United States

Medical University of South Carolina (MUSC) - Hollings Cancer Center

Charleston, South Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Centro de Diagnostico Urologico S.R.L.

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Hospital Sirio Libanes de Buenos Aires

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Fundacion Medica Rio Negro y Neuquen

Cipolletti, Argentina

Centro Medico Privado (CEMAIC)

Córdoba, Argentina

Fundación CORI para la investigación y Prevención del Cancer

La Rioja, Argentina

Centro De Investigacion Pergamino S.A.

Pergamino, Argentina

Instituto de Oncologia de Rosario

Santa Fe, Argentina

Clinica Viedma S.A.

Viedma, Argentina

Cancer Research SA

Adelaide, Australia

Mater Misericordiae Ltd, South Brisbane

Brisbane, Australia

Townsville Hospital and Health Service

Douglas, Australia

Barwon Health

Geelong, Australia

Calvary Mater Newcastle

Hunter, Australia

Sir Charles Gairdner Hospital

Nedlands, Australia

Blacktown Hospital

New South Wales, Australia

Icon Cancer Centre

South Brisbane, Australia

Gold Coast University Hospital

Southport, Australia

General Hospital Maria Middelares

Ghent, Belgium

University Hospital Gent

Ghent, Belgium

Fundacao PIO XII - Hospital de Amor

Barretos, Brazil

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina

Florianópolis, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

McGill University Health Center

Québec, Canada

Princess Margaret Hospital

Toronto, Canada

Fundación Arturo López Pérez (FALP)

Santiago, Chile

Centro de Investigacion Clinica Bradford Hill

Santiago, Chile

Oncocentro APYS

Viña del Mar, Chile

Service d'Oncologie Medicale - CHRU Besancon

Besançon, France

CHU Bordeaux - Hopital Saint-Andre

Bordeaux, France

Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo

Le Mans, France

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Institut Gustave Roussy

Villejuif, France

LTD High Technology Hospital Medcenter

Batumi, Georgia

The First University Clinic of Tbilisi State Medical University

Tbilisi, Georgia

New Vision University Hospital

Tbilisi, Georgia

Multiprofile Clinic Consilium Medulla LTD

Tbilisi, Georgia

Universitaetsklinikum Essen

Essen, Germany

Orszagos Onkologiai Intezet

Budapest, Hungary

Budapesti Uzsoki Utcai Korhaz

Budapest, Hungary

Rambam Health Care Campus

Haifa, Israel

Hadassah Hebrew University Medical Center

Jerusalem, Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Israel

Centro Riferimento Oncologico - Aviano

Aviano, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Naples, Italy

Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii

Gdansk, Poland

Mazowiecki Szpital Onkologiczny

Wieliszew, Poland

University Clinical Center of Serbia, Clinic of Urology

Belgrade, Serbia

National University Hospital

Singapore, Singapore

Chungnam National University Hospital

Daejeon, South Korea

National Cancer Center

Goyang, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Hospital Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

Hospital Universitario Donostia

San Sebastián, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Chi Mei Medical Center

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital (CGMHLK)

Taoyuan City, Taiwan

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

Istinye Universitesi VM Medical Park Pendik Hastanesi

Istanbul, Turkey (Türkiye)

Medical Point Izmir Hospital

Izmir, Turkey (Türkiye)

Kocaeli University Faculty of Medicine

Kocaeli, Turkey (Türkiye)

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

St. Bartholomew's Hospital

London, United Kingdom

University College London Hospital

London, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

The Royal Marsden Hospital

Sutton, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (102)