Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
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
3 other identifiers
interventional
132
6 countries
115
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2026
Typical duration for phase_1
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedStudy Start
First participant enrolled
March 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 5, 2028
July 22, 2026
July 1, 2026
1.7 years
February 12, 2026
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Confirmed Objective Response Rate (ORR) by investigator
ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator.
Up to approximately 3 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention.
Through 90 days after the last study intervention; Up to approximately 3 years
Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B
The number of participants who experienced DLTs in participants receiving PF-08634404 in combination with EV.
Through 90 days after the last study intervention; Up to approximately 3 years
Secondary Outcomes (6)
Duration of Response (DOR) per RECIST v1.1 by investigator
Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Up to approximately 3 years
Overall Survival (OS)
Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
Through 90 days after the last study intervention; Up to approximately 3 years
Pharmacokinetics (PK): Serum concentration of PF-08634404
Up to 37 days after the last dose of treatment
- +1 more secondary outcomes
Study Arms (2)
Cohort A
EXPERIMENTALParticipants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy.
Cohort B
EXPERIMENTALParticipants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin
Interventions
Powder for concentrate for solution for infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Astellas Pharma Inccollaborator
Study Sites (115)
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group, PA
Rogers, Arkansas, 72758, United States
Highlands Oncology Group, PA
Springdale, Arkansas, 72762, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
City of Hope Investigational Drug Services (IDS)
Duarte, California, 91010, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
City of Hope Investigational Drug Service (IDS)
Irvine, California, 92618, United States
City of Hope-Long Beach (ELM)
Long Beach, California, 90813, United States
City of Hope UPLAND
Upland, California, 91786, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Sibley Memorial Hospital Pharmacy Department
Washington D.C., District of Columbia, 20016, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Tennessee Oncology, PLLC- Ringgold
Ringgold, Georgia, 30736, United States
Memorial Hospital
Shiloh, Illinois, 62269, United States
Siteman Cancer Center - Shiloh
Shiloh, Illinois, 62269, United States
Oncology Research Pharmacy and lnvestigational Drug Service
Baltimore, Maryland, 21231, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center - North County
Florissant, Missouri, 63031, United States
Siteman Cancer Center
St Louis, Missouri, 63108, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
New York Oncology Hematology
Albany, New York, 12206, United States
New York Oncology Hematology
Clifton Park, New York, 12065, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227, United States
Oncology Associates of Oregon, P.C.
Springfield, Oregon, 97477, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223, United States
Tennessee Oncology, PLLC - Chattanooga Downtown
Chattanooga, Tennessee, 37403, United States
Tennessee Oncology, PLLC - Chattanooga Med Park II
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Chattanooga Memorial
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Chattanooga East
Chattanooga, Tennessee, 37421, United States
Tennessee Oncology, PLLC- Cookeville
Cookeville, Tennessee, 38501, United States
Tennessee Oncology, PLLC - Dickson
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC - Franklin
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC - Proton Center
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC - Gallatin
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC - Hendersonville
Hendersonville, Tennessee, 37075, United States
Tennessee Oncology, PLLC - Lebanon
Lebanon, Tennessee, 37090, United States
Tennessee Oncology, PLLC - Mount Juliet
Mount Juliet, Tennessee, 37122, United States
Tennessee Oncology, PLLC - Murfreesboro
Murfreesboro, Tennessee, 37129, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Investigational Drug Services
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Saint Thomas West
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC- Skyline
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC- Southern Hills
Nashville, Tennessee, 37211, United States
Tennessee Oncology, PLLC -Shelbyville
Shelbyville, Tennessee, 37160, United States
Tennessee Oncology, PLLC - Smyrna
Smyrna, Tennessee, 37167, United States
Texas Oncology - Central/South Texas
Austin, Texas, 78705, United States
Texas Oncology - Central/South Texas
Austin, Texas, 78731, United States
Texas Oncology - Central/South Texas
Austin, Texas, 78745, United States
Texas Oncology - Central South
Austin, Texas, 78758, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702, United States
Texas Oncology - Central/South Texas
Harlingen, Texas, 78550, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77024, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77054, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
Texas Oncology - Central/South Texas
McAllen, Texas, 78503, United States
Texas Oncology - Gulf Coast
Pearland, Texas, 77584, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380, United States
Texas Oncology - Central/South Texas
Waco, Texas, 76712, United States
Texas Oncology - Gulf Coast
Webster, Texas, 77598, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382, United States
Eye Associates Northwest - Edmonds Clinic
Edmonds, Washington, 98026, United States
Eye Associates Northwest - Kirkland Clinic
Kirkland, Washington, 98034, United States
Eye Associates Northwest - Ballard Clinic and Surgery Center
Seattle, Washington, 98104, United States
Eye Associates Northwest - First Hill Clinic
Seattle, Washington, 98104, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Eye Associates Northwest - Northgate Clinic
Seattle, Washington, 98125, United States
University Of Washington Medical Center
Seattle, Washington, 98195, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
Macquarie University
North Ryde, New South Wales, 2109, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, 315010, China
Keio university hospital
Shinjuku-ku, Tokyo, 1608582, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Pan American Center for Oncology Trials, LLC - Manati Office
Manati, 00674, Puerto Rico
Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez, 00680, Puerto Rico
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, 00935, Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [barcelona], 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], 08041, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2026
First Posted
February 19, 2026
Study Start
March 11, 2026
Primary Completion (Estimated)
December 6, 2027
Study Completion (Estimated)
September 5, 2028
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.