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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07421700

Registry updated: 2026-10-08
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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. 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.

Interventions

  • PF-08634404 (Biological)
    Concentrate for solution for Infusion.
  • Enfortumab Vedotin (Biological)
    Powder for concentrate for solution for infusion

Eligibility criteria

Inclusion Criteria: * 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 Criteria: Participants will be excluded if they meet any of the following: * 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 * Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression * Active autoimmune diseases requiring systemic treatment within the past 2 years * Participation in another investigational study within 30 days or 5 half-lives of the investigational product. * 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.

Conditions

Urothelial Cancer Advanced/Metastatic Urothelial Cancer Urothelial Carcinoma

Locations

  • Highlands Oncology Group, PA — Fayetteville, Arkansas, United States
  • Highlands Oncology Group, PA — Rogers, Arkansas, United States
  • Highlands Oncology Group, PA — Springdale, Arkansas, United States
  • UCLA Hematology/Oncology - Alhambra — Alhambra, California, United States
  • UCLA Hematology/Oncology - Atascadero — Atascadero, California, United States
  • UCLA Hematology/Oncology - Beverly Hills — Beverly Hills, California, United States
  • UCLA Hematology/Oncology - Burbank — Burbank, California, United States
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
  • City of Hope Investigational Drug Services (IDS) — Duarte, California, United States
  • UC San Diego Medical Center - Encinitas — Encinitas, California, United States
  • UCLA Hematology/Oncology - Encino — Encino, California, United States
  • UCLA Hematology/Oncology - Irvine — Irvine, California, United States
  • Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
  • UCI Health - Irvine Infusion Pharmacy ACC — Irvine, California, United States
  • City of Hope at Irvine Lennar — Irvine, California, United States
  • City of Hope Investigational Drug Service (IDS) — Irvine, California, United States
  • UC San Diego Koman Family Outpatient Pavilion — La Jolla, California, United States
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla, California, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • UC San Diego Shiley Eye Institute — La Jolla, California, United States
  • UC San Diego Sulpizio Cardiovascular Center — La Jolla, California, United States
  • Viterbi Family Department of Ophthalmology — La Jolla, California, United States
  • UCLA Hematology Oncology- Laguna Hills — Laguna Hills, California, United States
  • City of Hope-Long Beach (ELM) — Long Beach, California, United States
  • START Los Angeles, LLC — Los Angeles, California, United States
  • Los Angeles Cancer Network - Century City — Los Angeles, California, United States
  • (IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
  • UCLA Hematology/Oncology — Los Angeles, California, United States
  • UCLA Hematology/Oncology - Marina del Rey — Marina del Rey, California, United States
  • UC Irvine Health — Orange, California, United States
  • UCLA Hematology/Oncology - Pasadena — Pasadena, California, United States
  • UCLA Hematology Oncology - Porter Ranch — Porter Ranch, California, United States
  • UC San Diego Medical Center - Bankers Hill — San Diego, California, United States
  • UC San Diego McGrath Outpatient Pavilion - Hillcrest — San Diego, California, United States
  • UC San Diego Medical Center- Hillcrest — San Diego, California, United States
  • UC San Diego Medical Center - Rancho Bernardo — San Diego, California, United States
  • UCLA Hematology/Oncology - San Luis Obispo — San Luis Obispo, California, United States
  • UCLA Hematology/Oncology- Santa Barbara — Santa Barbara, California, United States
  • UCLA Hematology/Oncology- Santa Monica — Santa Monica, California, United States
  • UCLA Hematology/Oncology - Torrance — Torrance, California, United States
  • City of Hope UPLAND — Upland, California, United States
  • UCLA Hematology/Oncology - Santa Clarita — Valencia, California, United States
  • UCLA Hematology/Oncology - Ventura — Ventura, California, United States
  • UC San Diego Medical Center - Vista — Vista, California, United States
  • UCLA Hematology/Oncology - Westlake — Westlake Village, California, United States
  • Rocky Mountain Cancer Centers, LLP — Aurora, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States
  • Smilow Cancer Hospital - Derby — Derby, Connecticut, United States
  • Smilow Cancer Hospital - Fairfield — Fairfield, Connecticut, United States
  • Smilow Cancer Hospital - Greenwich — Greenwich, Connecticut, United States
  • Smilow Cancer Hospital - Guilford — Guilford, Connecticut, United States
  • Smilow Cancer Hospital - Yale New Haven Health — New Haven, Connecticut, United States
  • Yale Eye Center — New Haven, Connecticut, United States
  • Yale-New Haven Hospital-Yale Cancer Center — New Haven, Connecticut, United States
  • Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States
  • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP — New Haven, Connecticut, United States
  • Smilow Cancer Hospital - North Haven — North Haven, Connecticut, United States
  • Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States
  • Smilow Cancer Hospital - Long Ridge — Stamford, Connecticut, United States
  • Smilow Cancer Hospital - Trumbull — Trumbull, Connecticut, United States
  • Sibley Memorial Hospital Pharmacy Department — Washington D.C., District of Columbia, United States
  • Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
  • Tennessee Oncology, PLLC- Ringgold — Ringgold, Georgia, United States
  • Memorial Hospital — Shiloh, Illinois, United States
  • Siteman Cancer Center - Shiloh — Shiloh, Illinois, United States
  • Oncology Research Pharmacy and lnvestigational Drug Service — Baltimore, Maryland, United States
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
  • Johns Hopkins Hospital — Baltimore, Maryland, United States
  • Johns Hopkins Outpatient Center — Baltimore, Maryland, United States
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
  • Siteman Cancer Center - St. Peters — City of Saint Peters, Missouri, United States
  • Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
  • Siteman Cancer Center - North County — Florissant, Missouri, United States
  • Siteman Cancer Center — St Louis, Missouri, United States
  • Barnes-Jewish Hospital — St Louis, Missouri, United States
  • Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States
  • Siteman Cancer Center - South County — St Louis, Missouri, United States
  • MSK Basking Ridge — Basking Ridge, New Jersey, United States
  • MSK Monmouth — Middletown, New Jersey, United States
  • MSK Bergen — Montvale, New Jersey, United States
  • New York Oncology Hematology — Albany, New York, United States
  • New York Oncology Hematology — Clifton Park, New York, United States
  • MSK Commack — Commack, New York, United States
  • MSK Westchester — Harrison, New York, United States
  • Investigational Drug Service — Long Island City, New York, United States
  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
  • Evelyn H. Lauder Breast and Imaging Center (BAIC) — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center-Main Campus — New York, New York, United States
  • Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • MSK Nassau — Uniondale, New York, United States
  • Duke Cancer Center Cary — Cary, North Carolina, United States
  • Duke University Medical Center (location of scans) — Durham, North Carolina, United States
  • Duke University Medical Center - Duke University Hospital (location of scans) — Durham, North Carolina, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Duke University — Durham, North Carolina, United States
  • Duke Cancer Center Raleigh — Raleigh, North Carolina, United States
  • Duke Raleigh Hospital — Raleigh, North Carolina, United States
  • Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines) — Raleigh, North Carolina, United States
  • University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
  • Cleveland Clinic Foundation — Cleveland, Ohio, United States
  • Cleveland Clinic Taussig Cancer Center Investigational Pharmacy — Cleveland, Ohio, United States
  • Oncology Associates of Oregon, P.C. — Eugene, Oregon, United States
  • Northwest Cancer Specialists, P.C. — Portland, Oregon, United States
  • Northwest Cancer Specialists, P.C. — Portland, Oregon, United States
  • Oncology Associates of Oregon, P.C. — Springfield, Oregon, United States
  • Northwest Cancer Specialists, P.C. — Tigard, Oregon, United States
  • Tennessee Oncology, PLLC - Chattanooga Downtown — Chattanooga, Tennessee, United States
  • Tennessee Oncology, PLLC - Chattanooga Med Park II — Chattanooga, Tennessee, United States
  • Tennessee Oncology, PLLC - Chattanooga Memorial — Chattanooga, Tennessee, United States
  • Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage — Chattanooga, Tennessee, United States
  • Tennessee Oncology, PLLC - Chattanooga East — Chattanooga, Tennessee, United States
  • Tennessee Oncology, PLLC- Cookeville — Cookeville, Tennessee, United States
  • Tennessee Oncology, PLLC - Dickson — Dickson, Tennessee, United States
  • Tennessee Oncology, PLLC - Franklin — Franklin, Tennessee, United States
  • Tennessee Oncology, PLLC - Proton Center — Franklin, Tennessee, United States
  • Tennessee Oncology, PLLC - Gallatin — Gallatin, Tennessee, United States
  • Tennessee Oncology, PLLC - Hendersonville — Hendersonville, Tennessee, United States
  • Tennessee Oncology, PLLC - Lebanon — Lebanon, Tennessee, United States
  • Tennessee Oncology, PLLC - Mount Juliet — Mount Juliet, Tennessee, United States
  • Tennessee Oncology, PLLC - Murfreesboro — Murfreesboro, Tennessee, United States
  • Sarah Cannon Research Institute — Nashville, Tennessee, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology — Nashville, Tennessee, United States
  • Tennessee Oncology, PLLC - Investigational Drug Services — Nashville, Tennessee, United States
  • Tennessee Oncology, PLLC - Saint Thomas West — Nashville, Tennessee, United States
  • Tennessee Oncology, PLLC- Skyline — Nashville, Tennessee, United States
  • Tennessee Oncology, PLLC- Southern Hills — Nashville, Tennessee, United States
  • Tennessee Oncology, PLLC -Shelbyville — Shelbyville, Tennessee, United States
  • Tennessee Oncology, PLLC - Smyrna — Smyrna, Tennessee, United States
  • Texas Oncology - Central/South Texas — Austin, Texas, United States
  • Texas Oncology - Central/South Texas — Austin, Texas, United States
  • Texas Oncology - Central/South Texas — Austin, Texas, United States
  • Texas Oncology - Gulf Coast — Beaumont, Texas, United States
  • Texas Oncology - Central/South Texas — Harlingen, Texas, United States
  • Texas Oncology - Gulf Coast — Houston, Texas, United States
  • Texas Oncology - Gulf Coast — Houston, Texas, United States
  • US Oncology Investigational Product Center (IPC) — Irving, Texas, United States
  • US Oncology Investigational Products Center (IPC) — Irving, Texas, United States
  • Texas Oncology - Central/South Texas — McAllen, Texas, United States
  • Texas Oncology - Gulf Coast — Pearland, Texas, United States
  • Texas Oncology - Gulf Coast — Sugar Land, Texas, United States
  • Texas Oncology - Gulf Coast — The Woodlands, Texas, United States
  • Texas Oncology - Central/South Texas — Waco, Texas, United States
  • Texas Oncology - Gulf Coast — Webster, Texas, United States
  • Texas Oncology - Central South — Weslaco, Texas, United States
  • Huntsman Cancer Institute - University of Utah — Salt Lake City, Utah, United States
  • Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care — Blacksburg, Virginia, United States
  • Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
  • Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care — Low Moor, Virginia, United States
  • Virginia Oncology Associates — Norfolk, Virginia, United States
  • Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care — Roanoke, Virginia, United States
  • Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care — Salem, Virginia, United States
  • Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care — Wytheville, Virginia, United States
  • Eye Associates Northwest - Edmonds Clinic — Edmonds, Washington, United States
  • Eye Associates Northwest - Kirkland Clinic — Kirkland, Washington, United States
  • Eye Associates Northwest - Ballard Clinic and Surgery Center — Seattle, Washington, United States
  • Eye Associates Northwest - First Hill Clinic — Seattle, Washington, United States
  • Harborview Medical Center — Seattle, Washington, United States
  • Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • Eye Associates Northwest - Northgate Clinic — Seattle, Washington, United States
  • University Of Washington Medical Center — Seattle, Washington, United States
  • Northwest Cancer Specialists, P.C. — Vancouver, Washington, United States
  • Macquarie University — North Ryde, New South Wales, Australia
  • Icon Cancer Centre Wesley — Auchenflower, Queensland, Australia
  • Monash Health — Clayton, Victoria, Australia
  • Beijing Cancer hospital — Beijing, Beijing Municipality, China
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China
  • The Second Hospital of Tianjin Medical University — Tianjin, Tianjin Municipality, China
  • The first affiliated hospital of Ningbo university — Ningbo, Zhejiang, China
  • Keio university hospital — Shinjuku-ku, Tokyo, 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, Barcelona [barcelona], Spain
  • Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [barcelona], Spain
  • Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain
  • Hospital de la Santa Creu i Sant Pau — Barcelona, Catalunya [cataluña], Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Universitario Virgen Del Rocio — Seville, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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