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New hope for advanced bladder cancer: experimental drug combo enters late-stage trial

NCT ID NCT06225596

Disease control Sponsor: BicycleTx Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called BT8009, alone or with another drug (pembrolizumab), in people with advanced urothelial cancer that has spread. The goal is to see if it works better than standard chemotherapy. About 375 participants will be enrolled, some who have not had prior treatment and some who have. The study measures how long the cancer stays under control and any side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 375 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic urothelial cancer

Contacts and locations

Locations

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Barwon Health

    Geelong, 3220, Australia

  • Blacktown Hospital

    New South Wales, 2148, Australia

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED, United Kingdom

  • Budapesti Uzsoki Utcai Korhaz

    Budapest, H-1145, Hungary

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

    Florianópolis, 88020-210, Brazil

  • CHU Bordeaux - Hopital Saint-Andre

    Bordeaux, 33000, France

  • Calvary Mater Newcastle

    Hunter, 2310, Australia

  • Cancer Research SA

    Adelaide, 5000, Australia

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Centro De Investigacion Pergamino S.A.

    Pergamino, B2700CPM, Argentina

  • Centro Medico Privado (CEMAIC)

    Córdoba, X5008HHW, Argentina

  • Centro Riferimento Oncologico - Aviano

    Aviano, 33081, Italy

  • Centro de Diagnostico Urologico S.R.L.

    Buenos Aires, C1120AAT, Argentina

  • Centro de Investigacion Clinica Bradford Hill

    Santiago, 8420000, Chile

  • Chi Mei Medical Center

    Tainan, 710, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008, Spain

  • Clinica Viedma S.A.

    Viedma, 8500, Argentina

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

    Gdansk, 80-210, Poland

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Fundacao PIO XII - Hospital de Amor

    Barretos, 14784-400, Brazil

  • Fundacion Medica Rio Negro y Neuquen

    Cipolletti, R8324, Argentina

  • Fundación Arturo López Pérez (FALP)

    Santiago, 7500921, Chile

  • Fundación CORI para la investigación y Prevención del Cancer

    La Rioja, 5300, Argentina

  • General Hospital Maria Middelares

    Ghent, 9000, Belgium

  • Gold Coast University Hospital

    Southport, 4215, Australia

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

    Le Mans, 72000, France

  • HCL Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Hadassah Hebrew University Medical Center

    Jerusalem, 9112001, Israel

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01327-001, Brazil

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB, Argentina

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Sirio Libanes de Buenos Aires

    Buenos Aires, C1419AHN, Argentina

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Donostia

    San Sebastián, 20014, Spain

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Icon Cancer Centre

    South Brisbane, 4066, Australia

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, 08908, Spain

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ, Argentina

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Instituto de Oncologia de Rosario

    Santa Fe, S2000KZE, Argentina

  • Istinye Universitesi VM Medical Park Pendik Hastanesi

    Istanbul, 34899, Turkey (Türkiye)

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Naples, 80131, Italy

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kocaeli University Faculty of Medicine

    Kocaeli, 41380, Turkey (Türkiye)

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • LTD High Technology Hospital Medcenter

    Batumi, 6000, Georgia

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Taoyuan City, 333, Taiwan

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mater Misericordiae Ltd, South Brisbane

    Brisbane, 4101, Australia

  • Mazowiecki Szpital Onkologiczny

    Wieliszew, 05-135, Poland

  • McGill University Health Center

    Québec, H4A 3J1, Canada

  • Medical Point Izmir Hospital

    Izmir, 35575, Turkey (Türkiye)

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

    Charleston, South Carolina, 29425, United States

  • Moffitt

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Mount Sinai Medical Center of Florida, Inc.

    Miami Beach, Florida, 33140, United States

  • Multiprofile Clinic Consilium Medulla LTD

    Tbilisi, 0186, Georgia

  • National Cancer Center

    Goyang, 10408, South Korea

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Hospital

    Singapore, 119228, Singapore

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • New Vision University Hospital

    Tbilisi, 0159, Georgia

  • Oncocentro APYS

    Viña del Mar, 2520598, Chile

  • Orszagos Onkologiai Intezet

    Budapest, H-1122, Hungary

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132, Italy

  • Princess Margaret Hospital

    Toronto, M5G 2M9, Canada

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218, United States

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Service d'Oncologie Medicale - CHRU Besancon

    Besançon, 25000, France

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722, South Korea

  • Sir Charles Gairdner Hospital

    Nedlands, 6009, Australia

  • St. Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0141, Georgia

  • The Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Townsville Hospital and Health Service

    Douglas, QLD 4814, Australia

  • Trakya University Medical Faculty

    Edirne, 22030, Turkey (Türkiye)

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • University Clinical Center of Serbia, Clinic of Urology

    Belgrade, 11000, Serbia

  • University College London Hospital

    London, NW1 2PG, United Kingdom

  • University Hospital Gent

    Ghent, 9000, Belgium

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • UofL Health Brown Cancer Center

    Louisville, Kentucky, 40202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.