RecruitingPhase I/IIEN original

Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer

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About the trial

This study is being done to learn more about a new medicine called PF-08634404. It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA/mUC), meaning the cancer has spread to nearby tissues or other parts of the body. The purpose of the study is to see if PF-08634404 is safe, how well it works, how it moves through the body, and how it affects the cancer. The study will also look at how the medicine may change certain markers in the body that are linked to cancer. To join the study, participants must: * Be adults (18 years or older) and * Have locally advanced or metastatic urothelial cancer, The study has two groups: * Cohort A: People who have already received treatment for their cancer will get the study medicine ( PF-08634404) alone. * Cohort B: People who have not had treatment before will get the study medicine along with another cancer medicine called enfortumab vedotin. Everyone in the study will get the study medicine through a vein (IV infusion) with or without enfortumab vedotin. Treatment will continue as long as it helps and side effects are manageable. Before starting, participants will go through a screening period to check if they are eligible. During the study, they will have regular visits for treatment, health checks, and tests to see how the cancer is responding. Scans will be done regularly to monitor the cancer. If the cancer gets worse but the treatment is still helping and side effects are manageable, participants may be allowed to continue treatment with their doctor's and the sponsor's agreement.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Potwierdzony rozpoznaniem rak pęcherza moczowego, który rozprzestrzeniął się
  • Widoczne zmiany nowotworu widoczne w badaniach obrazowych
  • Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (ocena 0-1)
  • Prawidłowe funkcjonowanie nerek, wątroby i krwi
  • Zgoda na stosowanie antykoncepcji (osoby w wieku rozrodczym)
  • Zdolność i chęć do uczestniczenia w badaniu

✗ Disqualifies

  • Inny rak zdiagnozowany w ciągu ostatnich 3 lat
  • Przerzuty nowotworu do mózgu lub rdzenia kręgowego
  • Aktywna choroba autoimmunologiczna wymagająca leczenia
  • Uczestnictwo w innym badaniu klinicznym w ciągu ostatniego miesiąca
  • Ciąża lub karmienie piersią
  • Brak możliwości lub chęci do uczestniczenia w badaniu
  • Pracownik lub bliski członek rodziny pracownika badania

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 22, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (115)

Highlands Oncology Group, PA

Fayetteville, United States

Highlands Oncology Group, PA

Rogers, United States

Highlands Oncology Group, PA

Springdale, United States

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, United States

City of Hope Investigational Drug Services (IDS)

Duarte, United States

City of Hope at Irvine Lennar

Irvine, United States

City of Hope Investigational Drug Service (IDS)

Irvine, United States

City of Hope-Long Beach (ELM)

Long Beach, United States

City of Hope UPLAND

Upland, United States

Rocky Mountain Cancer Centers, LLP

Aurora, United States

Rocky Mountain Cancer Centers, LLP

Denver, United States

Rocky Mountain Cancer Centers, LLP

Lone Tree, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, United States

Sibley Memorial Hospital Pharmacy Department

Washington D.C., United States

Sibley Memorial Hospital

Washington D.C., United States

Tennessee Oncology, PLLC- Ringgold

Ringgold, United States

Memorial Hospital

Shiloh, United States

Siteman Cancer Center - Shiloh

Shiloh, United States

Oncology Research Pharmacy and lnvestigational Drug Service

Baltimore, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, United States

Johns Hopkins Hospital

Baltimore, United States

Johns Hopkins Outpatient Center

Baltimore, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, United States

Siteman Cancer Center - St. Peters

City of Saint Peters, United States

Siteman Cancer Center - West County

Creve Coeur, United States

Siteman Cancer Center - North County

Florissant, United States

Siteman Cancer Center

St Louis, United States

Barnes-Jewish Hospital

St Louis, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, United States

Siteman Cancer Center - South County

St Louis, United States

New York Oncology Hematology

Albany, United States

New York Oncology Hematology

Clifton Park, United States

Icahn School of Medicine at Mount Sinai

New York, United States

University Hospitals Cleveland Medical Center

Cleveland, United States

Oncology Associates of Oregon, P.C.

Eugene, United States

Northwest Cancer Specialists, P.C.

Portland, United States

Northwest Cancer Specialists, P.C.

Portland, United States

Oncology Associates of Oregon, P.C.

Springfield, United States

Northwest Cancer Specialists, P.C.

Tigard, United States

Tennessee Oncology, PLLC - Chattanooga Downtown

Chattanooga, United States

Tennessee Oncology, PLLC - Chattanooga Med Park II

Chattanooga, United States

Tennessee Oncology, PLLC - Chattanooga Memorial

Chattanooga, United States

Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage

Chattanooga, United States

Tennessee Oncology, PLLC - Chattanooga East

Chattanooga, United States

Tennessee Oncology, PLLC- Cookeville

Cookeville, United States

Tennessee Oncology, PLLC - Dickson

Dickson, United States

Tennessee Oncology, PLLC - Franklin

Franklin, United States

Tennessee Oncology, PLLC - Proton Center

Franklin, United States

Tennessee Oncology, PLLC - Gallatin

Gallatin, United States

Tennessee Oncology, PLLC - Hendersonville

Hendersonville, United States

Tennessee Oncology, PLLC - Lebanon

Lebanon, United States

Tennessee Oncology, PLLC - Mount Juliet

Mount Juliet, United States

Tennessee Oncology, PLLC - Murfreesboro

Murfreesboro, United States

Sarah Cannon Research Institute

Nashville, United States

SCRI Oncology Partners

Nashville, United States

Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology

Nashville, United States

Tennessee Oncology, PLLC - Investigational Drug Services

Nashville, United States

Tennessee Oncology, PLLC - Saint Thomas West

Nashville, United States

Tennessee Oncology, PLLC- Skyline

Nashville, United States

Tennessee Oncology, PLLC- Southern Hills

Nashville, United States

Tennessee Oncology, PLLC -Shelbyville

Shelbyville, United States

Tennessee Oncology, PLLC - Smyrna

Smyrna, United States

Texas Oncology - Central/South Texas

Austin, United States

Texas Oncology - Central/South Texas

Austin, United States

Texas Oncology - Central/South Texas

Austin, United States

Texas Oncology - Central South

Austin, United States

Texas Oncology - Gulf Coast

Beaumont, United States

Texas Oncology - Central/South Texas

Harlingen, United States

Texas Oncology - Gulf Coast

Houston, United States

Texas Oncology - Gulf Coast

Houston, United States

US Oncology Investigational Product Center (IPC)

Irving, United States

US Oncology Investigational Products Center (IPC)

Irving, United States

US Oncology Investigational Products Center (IPC)

Irving, United States

Texas Oncology - Central/South Texas

McAllen, United States

Texas Oncology - Gulf Coast

Pearland, United States

Texas Oncology - Gulf Coast

Sugar Land, United States

Texas Oncology - Gulf Coast

The Woodlands, United States

Texas Oncology - Central/South Texas

Waco, United States

Texas Oncology - Gulf Coast

Webster, United States

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Blacksburg, United States

Virginia Cancer Specialists, PC

Fairfax, United States

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Low Moor, United States

Virginia Oncology Associates

Norfolk, United States

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Roanoke, United States

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Salem, United States

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Wytheville, United States

Eye Associates Northwest - Edmonds Clinic

Edmonds, United States

Eye Associates Northwest - Kirkland Clinic

Kirkland, United States

Eye Associates Northwest - Ballard Clinic and Surgery Center

Seattle, United States

Eye Associates Northwest - First Hill Clinic

Seattle, United States

Harborview Medical Center

Seattle, United States

Fred Hutchinson Cancer Center

Seattle, United States

Eye Associates Northwest - Northgate Clinic

Seattle, United States

University Of Washington Medical Center

Seattle, United States

Northwest Cancer Specialists, P.C.

Vancouver, United States

Macquarie University

North Ryde, Australia

Icon Cancer Centre Wesley

Auchenflower, Australia

Monash Health

Clayton, Australia

Beijing Cancer hospital

Beijing, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, China

The Second Hospital of Tianjin Medical University

Tianjin, China

The first affiliated hospital of Ningbo university

Ningbo, China

Keio university hospital

Shinjuku-ku, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Yamagata University Hospital

Yamagata, Japan

Pan American Center for Oncology Trials, LLC - Manati Office

Manati, Puerto Rico

Pan American Center for Oncology Trials, LLC - Mayaguez Office

Mayagüez, Puerto Rico

Hospital Oncologico Dr. Isaac Gonzalez-Martinez

Rio Piedras, Puerto Rico

Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico

Parc de Salut Mar - Hospital del Mar

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.

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