Recruiting

Phase 1

Phase 2

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

Sponsor:

Pfizer

Code:

NCT07421700

Conditions

Urothelial Cancer

Advanced/Metastatic Urothelial Cancer

Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08634404

Enfortumab Vedotin

Study Details

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.

Conditions

Urothelial Cancer

Advanced/Metastatic Urothelial Cancer

Urothelial Carcinoma

Study ID

NCT07421700

Start date

Mar 11, 2026

Status verified date

Aug, 2026

Completion date

Sep 5, 2028

Anticipated

Primary completion date

Dec 6, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A

Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy.

experimental: Cohort B

Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin

Interventions

PF-08634404

Concentrate for solution for Infusion.

Enfortumab Vedotin

Powder for concentrate for solution for infusion

Primary outcome measure

Confirmed Objective Response Rate (ORR) by investigator [ Time Frame: Up to approximately 3 years ]
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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 [ Time Frame: Through 90 days after the last study intervention; Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Highlands Oncology Group, PA

Recruiting

Fayetteville, Arkansas, United States, 72703

Highlands Oncology Group, PA

Recruiting

Rogers, Arkansas, United States, 72758

Highlands Oncology Group, PA

Recruiting

Springdale, Arkansas, United States, 72762

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Recruiting

Duarte, California, United States, 91010

City of Hope Investigational Drug Services (IDS)

Recruiting

Duarte, California, United States, 91010

UC San Diego Medical Center - Encinitas

Recruiting

Encinitas, California, United States, 92024

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

City of Hope Investigational Drug Service (IDS)

Recruiting

Irvine, California, United States, 92618

UC San Diego Koman Family Outpatient Pavilion

Recruiting

La Jolla, California, United States, 92037

UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

Recruiting

La Jolla, California, United States, 92037

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

UC San Diego Shiley Eye Institute

Recruiting

La Jolla, California, United States, 92037

UC San Diego Sulpizio Cardiovascular Center

Recruiting

La Jolla, California, United States, 92037

Viterbi Family Department of Ophthalmology

Recruiting

La Jolla, California, United States, 92037

City of Hope-Long Beach (ELM)

Recruiting

Long Beach, California, United States, 90813

UC San Diego Medical Center - Bankers Hill

Recruiting

San Diego, California, United States, 92101

UC San Diego McGrath Outpatient Pavilion - Hillcrest

Recruiting

San Diego, California, United States, 92103

UC San Diego Medical Center- Hillcrest

Recruiting

San Diego, California, United States, 92103

UC San Diego Medical Center - Rancho Bernardo

Recruiting

San Diego, California, United States, 92127

City of Hope UPLAND

Recruiting

Upland, California, United States, 91786

UC San Diego Medical Center - Vista

Recruiting

Vista, California, United States, 92081

Rocky Mountain Cancer Centers, LLP

Recruiting

Aurora, Colorado, United States, 80012

Rocky Mountain Cancer Centers, LLP

Recruiting

Denver, Colorado, United States, 80218

Rocky Mountain Cancer Centers, LLP

Recruiting

Lone Tree, Colorado, United States, 80124

Eastern Connecticut Hematology and Oncology Associates

Recruiting

Norwich, Connecticut, United States, 06360

Sibley Memorial Hospital Pharmacy Department

Recruiting

Washington D.C., District of Columbia, United States, 20016

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Tennessee Oncology, PLLC- Ringgold

Recruiting

Ringgold, Georgia, United States, 30736

Memorial Hospital

Recruiting

Shiloh, Illinois, United States, 62269

Siteman Cancer Center - Shiloh

Recruiting

Shiloh, Illinois, United States, 62269

Oncology Research Pharmacy and lnvestigational Drug Service

Recruiting

Baltimore, Maryland, United States, 21231

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21231

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Johns Hopkins Outpatient Center

Recruiting

Baltimore, Maryland, United States, 21287

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Siteman Cancer Center - St. Peters

Recruiting

City of Saint Peters, Missouri, United States, 63376

Siteman Cancer Center - West County

Recruiting

Creve Coeur, Missouri, United States, 63141

Siteman Cancer Center - North County

Recruiting

Florissant, Missouri, United States, 63031

Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63108

Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Washington University School of Medicine - Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

Siteman Cancer Center - South County

Recruiting

St Louis, Missouri, United States, 63129

New York Oncology Hematology

Recruiting

Albany, New York, United States, 12206

New York Oncology Hematology

Recruiting

Clifton Park, New York, United States, 12065

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Duke Cancer Center Cary

Recruiting

Cary, North Carolina, United States, 27518

Duke University Medical Center (location of scans)

Recruiting

Durham, North Carolina, United States, 27710

Duke University Medical Center - Duke University Hospital (location of scans)

Recruiting

Durham, North Carolina, United States, 27710

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Duke University

Recruiting

Durham, North Carolina, United States, 27713

Duke Cancer Center Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Duke Raleigh Hospital

Recruiting

Raleigh, North Carolina, United States, 27609

Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)

Recruiting

Raleigh, North Carolina, United States, 27609

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Oncology Associates of Oregon, P.C.

Recruiting

Eugene, Oregon, United States, 97401

Northwest Cancer Specialists, P.C.

Recruiting

Portland, Oregon, United States, 97213

Northwest Cancer Specialists, P.C.

Recruiting

Portland, Oregon, United States, 97227

Oncology Associates of Oregon, P.C.

Recruiting

Springfield, Oregon, United States, 97477

Northwest Cancer Specialists, P.C.

Recruiting

Tigard, Oregon, United States, 97223

Tennessee Oncology, PLLC - Chattanooga Downtown

Recruiting

Chattanooga, Tennessee, United States, 37403

Tennessee Oncology, PLLC - Chattanooga Med Park II

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Oncology, PLLC - Chattanooga Memorial

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Oncology, PLLC - Chattanooga East

Recruiting

Chattanooga, Tennessee, United States, 37421

Tennessee Oncology, PLLC- Cookeville

Recruiting

Cookeville, Tennessee, United States, 38501

Tennessee Oncology, PLLC - Dickson

Recruiting

Dickson, Tennessee, United States, 37055

Tennessee Oncology, PLLC - Franklin

Recruiting

Franklin, Tennessee, United States, 37067

Tennessee Oncology, PLLC - Proton Center

Recruiting

Franklin, Tennessee, United States, 37067

Tennessee Oncology, PLLC - Gallatin

Recruiting

Gallatin, Tennessee, United States, 37066

Tennessee Oncology, PLLC - Hendersonville

Recruiting

Hendersonville, Tennessee, United States, 37075

Tennessee Oncology, PLLC - Lebanon

Recruiting

Lebanon, Tennessee, United States, 37090

Tennessee Oncology, PLLC - Mount Juliet

Recruiting

Mount Juliet, Tennessee, United States, 37122

Tennessee Oncology, PLLC - Murfreesboro

Recruiting

Murfreesboro, Tennessee, United States, 37129

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC - Investigational Drug Services

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC - Saint Thomas West

Recruiting

Nashville, Tennessee, United States, 37205

Tennessee Oncology, PLLC- Skyline

Recruiting

Nashville, Tennessee, United States, 37207

Tennessee Oncology, PLLC- Southern Hills

Recruiting

Nashville, Tennessee, United States, 37211

Tennessee Oncology, PLLC -Shelbyville

Recruiting

Shelbyville, Tennessee, United States, 37160

Tennessee Oncology, PLLC - Smyrna

Recruiting

Smyrna, Tennessee, United States, 37167

Texas Oncology - Central/South Texas

Recruiting

Austin, Texas, United States, 78705

Texas Oncology - Central/South Texas

Recruiting

Austin, Texas, United States, 78731

Texas Oncology - Central/South Texas

Recruiting

Austin, Texas, United States, 78745

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78758

Texas Oncology - Gulf Coast

Recruiting

Beaumont, Texas, United States, 77702

Texas Oncology - Central/South Texas

Recruiting

Harlingen, Texas, United States, 78550

Texas Oncology - Gulf Coast

Recruiting

Houston, Texas, United States, 77024

Texas Oncology - Gulf Coast

Recruiting

Houston, Texas, United States, 77054

US Oncology Investigational Product Center (IPC)

Recruiting

Irving, Texas, United States, 75063

US Oncology Investigational Products Center (IPC)

Recruiting

Irving, Texas, United States, 75063

Texas Oncology - Central/South Texas

Recruiting

McAllen, Texas, United States, 78503

Texas Oncology - Gulf Coast

Recruiting

Pearland, Texas, United States, 77584

Texas Oncology - Gulf Coast

Recruiting

Sugar Land, Texas, United States, 77479

Texas Oncology - Gulf Coast

Recruiting

The Woodlands, Texas, United States, 77380

Texas Oncology - Central/South Texas

Recruiting

Waco, Texas, United States, 76712

Texas Oncology - Gulf Coast

Recruiting

Webster, Texas, United States, 77598

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Recruiting

Blacksburg, Virginia, United States, 24060

Virginia Cancer Specialists, PC

Recruiting

Fairfax, Virginia, United States, 22031

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Recruiting

Low Moor, Virginia, United States, 24457

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Recruiting

Roanoke, Virginia, United States, 24014

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Recruiting

Salem, Virginia, United States, 24153

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Recruiting

Wytheville, Virginia, United States, 24382

Eye Associates Northwest - Edmonds Clinic

Recruiting

Edmonds, Washington, United States, 98026

Eye Associates Northwest - Kirkland Clinic

Recruiting

Kirkland, Washington, United States, 98034

Eye Associates Northwest - Ballard Clinic and Surgery Center

Recruiting

Seattle, Washington, United States, 98104

Eye Associates Northwest - First Hill Clinic

Recruiting

Seattle, Washington, United States, 98104

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Eye Associates Northwest - Northgate Clinic

Recruiting

Seattle, Washington, United States, 98125

University Of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Northwest Cancer Specialists, P.C.

Recruiting

Vancouver, Washington, United States, 98684

More Information

Sponsor

Pfizer

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

urothelial cancer
metastatic urothelial cancer
locally advanced urothelial cancer
bladder cancer
urothelial carcinoma
PD-1
VEGF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-17.