Taking people in United StatesPhase 1/2

PF-08634404 Alone or With Enfortumab Vedotin for Advanced Urothelial Cancer

Tests PF-08634404, alone or with enfortumab vedotin, in adults with advanced urothelial cancer.

Plain-language title generated from the registry record
Registry title: Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer

Key facts

Where: Albany, Alhambra, Atascadero, Aurora, Austin, Baltimore, Basking Ridge, Beaumont, Beverly Hills, Blacksburg, Burbank, Cary, Chattanooga, City of Saint Peters, Cleveland, Clifton Park, Commack, Cookeville, Creve Coeur, Denver, Derby, Dickson, Duarte, Durham, Edmonds, Encinitas, Encino, Eugene, Fairfax, Fairfield, Fayetteville, Florissant, Franklin, Gallatin, Greenwich, Guilford, Harlingen, Harrison, Hendersonville, Houston, Irvine, Irving, Kirkland, La Jolla, Laguna Hills, Lebanon, Lone Tree, Long Beach, Long Island City, Los Angeles, Low Moor, Marina del Rey, McAllen, Middletown, Montvale, Mount Juliet, Murfreesboro, Nashville, New Haven, New York, Norfolk, North Haven, Norwich, Orange, Pasadena, Pearland, Porter Ranch, Portland, Raleigh, Ringgold, Roanoke, Rogers, Salem, Salt Lake City, San Diego, San Luis Obispo, Santa Barbara, Santa Monica, Seattle, Shelbyville, Shiloh, Smyrna, Springdale, Springfield, St Louis, Stamford, Sugar Land, The Woodlands, Tigard, Torrance, Trumbull, Uniondale, Upland, Valencia, Vancouver, Ventura, Vista, Waco, Washington D.C., Webster, Weslaco, Westlake Village, and Wytheville, United StatesSee the 159 sites
Phase: Phase 1/2

Where in United States

New York Oncology HematologyAlbany, United StatesTaking people
UCLA Hematology/Oncology - AlhambraAlhambra, United StatesTaking people
UCLA Hematology/Oncology - AtascaderoAtascadero, United StatesTaking people
Rocky Mountain Cancer Centers,LLPAurora, United StatesTaking people
Texas Oncology - Central/South TexasAustin, United StatesTaking people
Johns Hopkins HospitalBaltimore, United StatesTaking people
Johns Hopkins Outpatient CenterBaltimore, United StatesTaking people
Oncology Research Pharmacy and lnvestigational Drug ServiceBaltimore, United StatesTaking people
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, United StatesTaking people
MSK Basking Ridge.Basking Ridge, United StatesNot yet recruiting
Texas Oncology - Gulf CoastBeaumont, United StatesTaking people
UCLA Hematology/Oncology - Beverly HillsBeverly Hills, United StatesTaking people
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareBlacksburg, United StatesTaking people
UCLA Hematology/Oncology - BurbankBurbank, United StatesTaking people
Duke Cancer Center CaryCary, United StatesTaking people
Tennessee Oncology, PLLC - Chattanooga DowntownChattanooga, United StatesTaking people
Tennessee Oncology, PLLC - Chattanooga EastChattanooga, United StatesTaking people
Tennessee Oncology, PLLC - Chattanooga Med Park IIChattanooga, United StatesTaking people
Tennessee Oncology, PLLC - Chattanooga MemorialChattanooga, United StatesTaking people
Tennessee Oncology, PLLC - Investigational Drug Services/Supply StorageChattanooga, United StatesTaking people
Siteman Cancer Center - St PetersCity of Saint Peters, United StatesTaking people
Cleveland Clinic FoundationCleveland, United StatesTaking people
Cleveland Clinic Taussig Cancer Center Investigational PharmacyCleveland, United StatesTaking people
University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
New York Oncology/HematologyClifton Park, United StatesTaking people
MSK Commack.Commack, United StatesNot yet recruiting
Tennessee Oncology, PLLC - CookevilleCookeville, United StatesTaking people
Siteman Cancer Center - West CountyCreve Coeur, United StatesTaking people
Rocky Mountain Cancer Centers, LLPDenver, United StatesTaking people
Smilow Cancer Hospital - DerbyDerby, United StatesTaking people
Tennessee Oncology, PLLC - DicksonDickson, United StatesTaking people
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, United StatesTaking people
City of Hope Investigational Drug Services (IDS)Duarte, United StatesTaking people
Duke UniversityDurham, United StatesTaking people
Duke University Medical CenterDurham, United StatesTaking people
Duke University Medical Center - Duke University Hospital (location of scans)Durham, United StatesTaking people
Duke University Medical Center (location of scans)Durham, United StatesTaking people
Eye Associates Northwest - Edmonds ClinicEdmonds, United StatesTaking people
UC San Diego Medical Center - EncinitasEncinitas, United StatesTaking people
UCLA Hematology/Oncology - EncinoEncino, United StatesTaking people
Oncology Associates of Oregon, P.C.Eugene, United StatesTaking people
Virginia Cancer Specialists PCFairfax, United StatesTaking people
Smilow Cancer Hospital - FairfieldFairfield, United StatesTaking people
Highlands Oncology Group, PAFayetteville, United StatesTaking people
Siteman Cancer Center - North CountyFlorissant, United StatesTaking people
Tennessee Oncology, PLLC - FranklinFranklin, United StatesTaking people
Tennessee Oncology, PLLC - Proton CenterFranklin, United StatesTaking people
Tennessee Oncology, PLLC - GallatinGallatin, United StatesTaking people
Smilow Cancer Hospital - GreenwichGreenwich, United StatesTaking people
Smilow Cancer Hospital - GuilfordGuilford, United StatesTaking people
Texas Oncology - Central/South TexasHarlingen, United StatesTaking people
MSK Westchester.Harrison, United StatesNot yet recruiting
Tennessee Oncology, PLLC - HendersonvilleHendersonville, United StatesTaking people
Texas Oncology - Gulf CoastHouston, United StatesTaking people
Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, United StatesTaking people
City of Hope at Irvine LennarIrvine, United StatesTaking people
City of Hope Investigational Drug Service (IDS)Irvine, United StatesTaking people
UCI Health - Irvine Infusion Pharmacy ACCIrvine, United StatesTaking people
UCLA Hematology/ Oncology- IrvineIrvine, United StatesTaking people
US Oncology Investigational Product Center (IPC)Irving, United StatesTaking people
US Oncology Investigational Products Center (IPC)Irving, United StatesTaking people
Eye Associates Northwest - Kirkland ClinicKirkland, United StatesTaking people
UC San Diego Koman Family Outpatient PavilionLa Jolla, United StatesTaking people
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)La Jolla, United StatesTaking people
UC San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
UC San Diego Shiley Eye InstituteLa Jolla, United StatesTaking people
UC San Diego Sulpizio Cardiovascular CenterLa Jolla, United StatesTaking people
Viterbi Family Department of OphthalmologyLa Jolla, United StatesTaking people
UCLA Hematology/Oncology - Laguna HillsLaguna Hills, United StatesTaking people
Tennessee Oncology, PLLC - LebanonLebanon, United StatesTaking people
Rocky Mountain Cancer Centers,LLPLone Tree, United StatesTaking people
City of Hope Long Beach ElmLong Beach, United StatesTaking people
Investigational Drug ServiceLong Island City, United StatesNot yet recruiting
(IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information CenterLos Angeles, United StatesTaking people
Los Angeles Cancer Network_Century CityLos Angeles, United StatesTaking people
START Los Angeles, LLCLos Angeles, United StatesTaking people
UCLA Hematology-OncologyLos Angeles, United StatesTaking people
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareLow Moor, United StatesTaking people
UCLA Hematology/Oncology - Marina del ReyMarina del Rey, United StatesTaking people
Texas Oncology - Central/South TexasMcAllen, United StatesTaking people
MSK Monmouth.Middletown, United StatesNot yet recruiting
MSK Bergen.Montvale, United StatesNot yet recruiting
Tennessee Oncology, PLLC - Mount JulietMount Juliet, United StatesTaking people
Tennessee Oncology, PLLC - MurfreesboroMurfreesboro, United StatesTaking people
Sarah Cannon Research InstituteNashville, United StatesTaking people
SCRI Oncology PartnersNashville, United StatesTaking people
Tennessee Oncology, PLLC - Investigational Drug ServicesNashville, United StatesTaking people
Tennessee Oncology, PLLC - Saint Thomas WestNashville, United StatesTaking people
Tennessee Oncology, PLLC- SkylineNashville, United StatesTaking people
Tennessee Oncology, PLLC- Southern HillsNashville, United StatesTaking people
Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &HematologyNashville, United StatesTaking people
Smilow Cancer Hospital - Yale New Haven HealthNew Haven, United StatesTaking people
Smilow Cancer Hospital Phase 1 UnitNew Haven, United StatesTaking people
Yale - New Haven Hospital - Yale Cancer CenterNew Haven, United StatesTaking people
Yale Eye CenterNew Haven, United StatesTaking people
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOPNew Haven, United StatesTaking people
Evelyn H. Lauder Breast and Imaging Center (BAIC).New York, United StatesNot yet recruiting
Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).New York, United StatesNot yet recruiting
Memorial Sloan Kettering Cancer Center - Main CampusNew York, United StatesNot yet recruiting
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer CenterNew York, United StatesNot yet recruiting
Virginia Oncology AssociatesNorfolk, United StatesTaking people
Smilow Cancer Hospital - North HavenNorth Haven, United StatesTaking people
Eastern Connecticut Hematology and Oncology AssociatesNorwich, United StatesTaking people
UC Irvine HealthOrange, United StatesTaking people
UCLA Hematology/Oncology - PasadenaPasadena, United StatesTaking people
Texas Oncology - Gulf CoastPearland, United StatesTaking people
UCLA Hematology/Oncology - Porter RanchPorter Ranch, United StatesTaking people
Northwest Cancer Specialists, P.C.Portland, United StatesTaking people
Duke Cancer Center RaleighRaleigh, United StatesTaking people
Duke Raleigh HospitalRaleigh, United StatesTaking people
Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)Raleigh, United StatesTaking people
Tennessee Oncology, PLLC - RinggoldRinggold, United StatesTaking people
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareRoanoke, United StatesTaking people
Highlands Oncology Group, PARogers, United StatesTaking people
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareSalem, United StatesTaking people
Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
UC San Diego McGrath Outpatient Pavilion - HillcrestSan Diego, United StatesTaking people
UC San Diego Medical Center - Bankers HillSan Diego, United StatesTaking people
UC San Diego Medical Center - HillcrestSan Diego, United StatesTaking people
UC San Diego Medical Center - Rancho BernardoSan Diego, United StatesTaking people
UCLA Hematology/Oncology - San Luis ObispoSan Luis Obispo, United StatesTaking people
UCLA Hematology/Oncology- Santa BarbaraSanta Barbara, United StatesTaking people
UCLA Hematology-Oncology - Santa MonicaSanta Monica, United StatesTaking people
Eye Associates Northwest - Ballard Clinic and Surgery CenterSeattle, United StatesTaking people
Eye Associates Northwest - First Hill ClinicSeattle, United StatesTaking people
Eye Associates Northwest - Northgate ClinicSeattle, United StatesTaking people
Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
Harborview Medical CenterSeattle, United StatesTaking people
University of Washington Medical CenterSeattle, United StatesTaking people
Tennessee Oncology, PLLC -ShelbyvilleShelbyville, United StatesTaking people
Memorial HospitalShiloh, United StatesTaking people
Siteman Cancer Center - ShilohShiloh, United StatesTaking people
Tennessee Oncology, PLLC - SmyrnaSmyrna, United StatesTaking people
Highlands Oncology Group, PASpringdale, United StatesTaking people
Oncology Associates of Oregon, P.C.Springfield, United StatesTaking people
Barnes-Jewish HospitalSt Louis, United StatesTaking people
Siteman Cancer CenterSt Louis, United StatesTaking people
Siteman Cancer Center-South CountySt Louis, United StatesTaking people
Washington University School of Medicine - Siteman Cancer CenterSt Louis, United StatesTaking people
Smilow Cancer Hospital - Long RidgeStamford, United StatesTaking people
Texas Oncology - Gulf CoastSugar Land, United StatesTaking people
Texas Oncology- Gulf CoastThe Woodlands, United StatesTaking people
Northwest Cancer Specialists, P.C.Tigard, United StatesTaking people
UCLA Hematology/Oncology - TorranceTorrance, United StatesTaking people
Smilow Cancer Hospital - TrumbullTrumbull, United StatesTaking people
MSK Nassau.Uniondale, United StatesNot yet recruiting
City of Hope UplandUpland, United StatesTaking people
UCLA Hematology/Oncology - Santa ClaritaValencia, United StatesTaking people
Northwest Cancer Specialists, P.C.Vancouver, United StatesTaking people
UCLA Hematology/Oncology - VenturaVentura, United StatesTaking people
UC San Diego Medical Center - VistaVista, United StatesTaking people
Texas Oncology - Central/South TexasWaco, United StatesTaking people
Sibley Memorial HospitalWashington D.C., United StatesTaking people
Sibley Memorial Hospital Pharmacy DepartmentWashington D.C., United StatesTaking people
Texas Oncology - Gulf CoastWebster, United StatesTaking people
Texas Oncology - Central SouthWeslaco, United StatesTaking people
UCLA Hematology/Oncology- WestlakeWestlake Village, United StatesTaking people
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareWytheville, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Print a page for my doctor

Trial details

Who runs it: Pfizer
Trial code: NCT07421700 EU 2025-523523-21-00
Record updated: 8 October 2026
Original description: 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.Read full original descriptionShow less
AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER
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.
Inclusion: Age ≥18 years at the time of screening; Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA/mUC); Measurable disease per RECIST v1.1 criteria; ECOG performance status of 0 or 1; Adequate organ function, including hematologic, hepatic, and renal parameters; Willingness to comply with study procedures and provide informed consent; For participants of childbearing potential: agreement to use effective contraception during the study and for a defined period after the last dose.
Exclusion: Participation in another investigational study within 30 days or 5 half-lives of the investigational product; History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy; Active autoimmune diseases requiring systemic treatment within the past 2 years; Participants will be excluded if they meet any of the following:; Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression; Pregnant or breastfeeding individuals; Inability or unwillingness to comply with study requirements; Study staff or their immediate family members directly involved in the conduct of the study.
ClinicalTrials.gov NCT07421700 · EU CTIS 2025-523523-21-00