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Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
Sponsor: Pfizer
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2026-03-11
Completion Date
2028-09-05
Last Updated
2026-08-17
Healthy Volunteers
No
Interventions
PF-08634404
Concentrate for solution for Infusion.
Enfortumab Vedotin
Powder for concentrate for solution for infusion
Locations (153)
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
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
(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
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
Eastern Connecticut Hematology and Oncology Associates
Norwich, 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
New York Oncology Hematology
Albany, New York, United States
New York Oncology Hematology
Clifton Park, New York, United States
Icahn School of Medicine at Mount Sinai
New York, 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
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 - Central South
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
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