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Recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT07421700

Public ClinicalTrials.gov record NCT07421700. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 1:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07421700
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Pfizer
Industry
Enrollment
132 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 10, 2026
Primary completion
Dec 5, 2027
Completion
Sep 4, 2028
Last update posted
Aug 16, 2026

2026 – 2028

United States locations

U.S. sites
133
U.S. states
17
U.S. cities
85
Facility City State ZIP Site status
Highlands Oncology Group, PA Fayetteville Arkansas 72703 Recruiting
Highlands Oncology Group, PA Rogers Arkansas 72758 Recruiting
Highlands Oncology Group, PA Springdale Arkansas 72762 Recruiting
UCLA Hematology/Oncology - Alhambra Alhambra California 91801 Not yet recruiting
UCLA Hematology/Oncology - Atascadero Atascadero California 93422 Not yet recruiting
UCLA Hematology/Oncology - Beverly Hills Beverly Hills California 90212 Not yet recruiting
UCLA Hematology/Oncology - Burbank Burbank California 91505 Not yet recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Duarte California 91010 Recruiting
City of Hope Investigational Drug Services (IDS) Duarte California 91010 Recruiting
UC San Diego Medical Center - Encinitas Encinitas California 92024 Recruiting
UCLA Hematology/Oncology - Encino Encino California 91436 Not yet recruiting
UCLA Hematology/Oncology - Irvine Irvine California 92604 Not yet recruiting
City of Hope at Irvine Lennar Irvine California 92618 Recruiting
City of Hope Investigational Drug Service (IDS) Irvine California 92618 Recruiting
UC San Diego Koman Family Outpatient Pavilion La Jolla California 92037 Recruiting
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) La Jolla California 92037 Recruiting
UC San Diego Moores Cancer Center La Jolla California 92037 Recruiting
UC San Diego Shiley Eye Institute La Jolla California 92037 Recruiting
UC San Diego Sulpizio Cardiovascular Center La Jolla California 92037 Recruiting
Viterbi Family Department of Ophthalmology La Jolla California 92037 Recruiting
UCLA Hematology Oncology- Laguna Hills Laguna Hills California 92653 Not yet recruiting
City of Hope-Long Beach (ELM) Long Beach California 90813 Recruiting
(IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center Los Angeles California 90095 Not yet recruiting
UCLA Hematology/Oncology Los Angeles California 90095 Not yet recruiting
UCLA Hematology/Oncology - Marina del Rey Marina del Rey California 90292 Not yet recruiting
UCLA Hematology/Oncology - Pasadena Pasadena California 91105 Not yet recruiting
UCLA Hematology Oncology - Porter Ranch Porter Ranch California 91326 Not yet recruiting
UC San Diego Medical Center - Bankers Hill San Diego California 92101 Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest San Diego California 92103 Recruiting
UC San Diego Medical Center- Hillcrest San Diego California 92103 Recruiting
UC San Diego Medical Center - Rancho Bernardo San Diego California 92127 Recruiting
UCLA Hematology/Oncology - San Luis Obispo San Luis Obispo California 93401 Not yet recruiting
UCLA Hematology/Oncology- Santa Barbara Santa Barbara California 93101 Not yet recruiting
UCLA Hematology/Oncology- Santa Monica Santa Monica California 90404 Not yet recruiting
UCLA Hematology/Oncology - Torrance Torrance California 90505 Not yet recruiting
City of Hope UPLAND Upland California 91786 Recruiting
UCLA Hematology/Oncology - Santa Clarita Valencia California 91355 Not yet recruiting
UCLA Hematology/Oncology - Ventura Ventura California 93003 Not yet recruiting
UC San Diego Medical Center - Vista Vista California 92081 Recruiting
UCLA Hematology/Oncology - Westlake Westlake Village California 91361 Not yet recruiting
Rocky Mountain Cancer Centers, LLP Aurora Colorado 80012 Recruiting
Rocky Mountain Cancer Centers, LLP Denver Colorado 80218 Recruiting
Rocky Mountain Cancer Centers, LLP Lone Tree Colorado 80124 Recruiting
Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut 06360 Recruiting
Sibley Memorial Hospital Pharmacy Department Washington D.C. District of Columbia 20016 Recruiting
Sibley Memorial Hospital Washington D.C. District of Columbia 20016 Recruiting
Tennessee Oncology, PLLC- Ringgold Ringgold Georgia 30736 Recruiting
Memorial Hospital Shiloh Illinois 62269 Recruiting
Siteman Cancer Center - Shiloh Shiloh Illinois 62269 Recruiting
Oncology Research Pharmacy and lnvestigational Drug Service Baltimore Maryland 21231 Recruiting
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21231 Recruiting
Johns Hopkins Hospital Baltimore Maryland 21287 Recruiting
Johns Hopkins Outpatient Center Baltimore Maryland 21287 Recruiting
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21287 Recruiting
Siteman Cancer Center - St. Peters City of Saint Peters Missouri 63376 Recruiting
Siteman Cancer Center - West County Creve Coeur Missouri 63141 Recruiting
Siteman Cancer Center - North County Florissant Missouri 63031 Recruiting
Siteman Cancer Center St Louis Missouri 63108 Recruiting
Barnes-Jewish Hospital St Louis Missouri 63110 Recruiting
Washington University School of Medicine - Siteman Cancer Center St Louis Missouri 63110 Recruiting
Siteman Cancer Center - South County St Louis Missouri 63129 Recruiting
New York Oncology Hematology Albany New York 12206 Recruiting
New York Oncology Hematology Clifton Park New York 12065 Recruiting
Icahn School of Medicine at Mount Sinai New York New York 10029 Recruiting
Duke Cancer Center Cary Cary North Carolina 27518 Recruiting
Duke University Medical Center (location of scans) Durham North Carolina 27710 Recruiting
Duke University Medical Center - Duke University Hospital (location of scans) Durham North Carolina 27710 Recruiting
Duke University Medical Center Durham North Carolina 27710 Recruiting
Duke University Durham North Carolina 27713 Recruiting
Duke Cancer Center Raleigh Raleigh North Carolina 27609 Recruiting
Duke Raleigh Hospital Raleigh North Carolina 27609 Recruiting
Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines) Raleigh North Carolina 27609 Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 Recruiting
Oncology Associates of Oregon, P.C. Eugene Oregon 97401 Recruiting
Northwest Cancer Specialists, P.C. Portland Oregon 97213 Recruiting
Northwest Cancer Specialists, P.C. Portland Oregon 97227 Recruiting
Oncology Associates of Oregon, P.C. Springfield Oregon 97477 Recruiting
Northwest Cancer Specialists, P.C. Tigard Oregon 97223 Recruiting
Tennessee Oncology, PLLC - Chattanooga Downtown Chattanooga Tennessee 37403 Recruiting
Tennessee Oncology, PLLC - Chattanooga Med Park II Chattanooga Tennessee 37404 Recruiting
Tennessee Oncology, PLLC - Chattanooga Memorial Chattanooga Tennessee 37404 Recruiting
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage Chattanooga Tennessee 37404 Recruiting
Tennessee Oncology, PLLC - Chattanooga East Chattanooga Tennessee 37421 Recruiting
Tennessee Oncology, PLLC- Cookeville Cookeville Tennessee 38501 Recruiting
Tennessee Oncology, PLLC - Dickson Dickson Tennessee 37055 Recruiting
Tennessee Oncology, PLLC - Franklin Franklin Tennessee 37067 Recruiting
Tennessee Oncology, PLLC - Proton Center Franklin Tennessee 37067 Recruiting
Tennessee Oncology, PLLC - Gallatin Gallatin Tennessee 37066 Recruiting
Tennessee Oncology, PLLC - Hendersonville Hendersonville Tennessee 37075 Recruiting
Tennessee Oncology, PLLC - Lebanon Lebanon Tennessee 37090 Recruiting
Tennessee Oncology, PLLC - Mount Juliet Mount Juliet Tennessee 37122 Recruiting
Tennessee Oncology, PLLC - Murfreesboro Murfreesboro Tennessee 37129 Recruiting
Sarah Cannon Research Institute Nashville Tennessee 37203 Recruiting
SCRI Oncology Partners Nashville Tennessee 37203 Recruiting
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology Nashville Tennessee 37203 Recruiting
Tennessee Oncology, PLLC - Investigational Drug Services Nashville Tennessee 37203 Recruiting
Tennessee Oncology, PLLC - Saint Thomas West Nashville Tennessee 37205 Recruiting
Tennessee Oncology, PLLC- Skyline Nashville Tennessee 37207 Recruiting
Tennessee Oncology, PLLC- Southern Hills Nashville Tennessee 37211 Recruiting
Tennessee Oncology, PLLC -Shelbyville Shelbyville Tennessee 37160 Recruiting
Tennessee Oncology, PLLC - Smyrna Smyrna Tennessee 37167 Recruiting
Texas Oncology - Central/South Texas Austin Texas 78705 Recruiting
Texas Oncology - Central/South Texas Austin Texas 78731 Recruiting
Texas Oncology - Central/South Texas Austin Texas 78745 Recruiting
Texas Oncology - Central South Austin Texas 78758 Recruiting
Texas Oncology - Gulf Coast Beaumont Texas 77702 Recruiting
Texas Oncology - Central/South Texas Harlingen Texas 78550 Recruiting
Texas Oncology - Gulf Coast Houston Texas 77024 Recruiting
Texas Oncology - Gulf Coast Houston Texas 77054 Recruiting
US Oncology Investigational Product Center (IPC) Irving Texas 75063 Recruiting
US Oncology Investigational Products Center (IPC) Irving Texas 75063 Recruiting
Texas Oncology - Central/South Texas McAllen Texas 78503 Recruiting
Texas Oncology - Gulf Coast Pearland Texas 77584 Recruiting
Texas Oncology - Gulf Coast Sugar Land Texas 77479 Recruiting
Texas Oncology - Gulf Coast The Woodlands Texas 77380 Recruiting
Texas Oncology - Central/South Texas Waco Texas 76712 Recruiting
Texas Oncology - Gulf Coast Webster Texas 77598 Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care Blacksburg Virginia 24060 Recruiting
Virginia Cancer Specialists, PC Fairfax Virginia 22031 Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care Low Moor Virginia 24457 Recruiting
Virginia Oncology Associates Norfolk Virginia 23502 Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care Roanoke Virginia 24014 Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care Salem Virginia 24153 Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care Wytheville Virginia 24382 Recruiting
Eye Associates Northwest - Edmonds Clinic Edmonds Washington 98026 Recruiting
Eye Associates Northwest - Kirkland Clinic Kirkland Washington 98034 Recruiting
Eye Associates Northwest - Ballard Clinic and Surgery Center Seattle Washington 98104 Recruiting
Eye Associates Northwest - First Hill Clinic Seattle Washington 98104 Recruiting
Harborview Medical Center Seattle Washington 98104 Recruiting
Fred Hutchinson Cancer Center Seattle Washington 98109 Recruiting
Eye Associates Northwest - Northgate Clinic Seattle Washington 98125 Recruiting
University Of Washington Medical Center Seattle Washington 98195 Recruiting
Northwest Cancer Specialists, P.C. Vancouver Washington 98684 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07421700, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 16, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07421700 live on ClinicalTrials.gov.

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