New hope for bladder cancer: experimental drug trial now recruiting

NCT ID NCT07421700

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 6 times

Summary

This study tests a new medicine, PF-08634404, in adults with advanced bladder cancer that has spread. Some participants receive the drug alone, while others get it combined with another cancer drug. The goal is to check safety, how well it works, and how it affects the body. About 132 people will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma transitional cell carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced/metastatic urothelial cancer Urothelial cancer Urothelial carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

153 sites in 6 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

(IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
Barnes-Jewish Hospital
RECRUITING

St Louis, Missouri, 63110, United States
Beijing Cancer hospital
RECRUITING

Beijing, Beijing Municipality, 100142, China
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
RECRUITING

Duarte, California, 91010, United States
City of Hope Investigational Drug Service (IDS)
RECRUITING

Irvine, California, 92618, United States
City of Hope Investigational Drug Services (IDS)
RECRUITING

Duarte, California, 91010, United States
City of Hope UPLAND
RECRUITING

Upland, California, 91786, United States
City of Hope at Irvine Lennar
RECRUITING

Irvine, California, 92618, United States
City of Hope-Long Beach (ELM)
RECRUITING

Long Beach, California, 90813, United States
Duke Cancer Center Cary
RECRUITING

Cary, North Carolina, 27518, United States
Duke Cancer Center Raleigh
RECRUITING

Raleigh, North Carolina, 27609, United States
Duke Raleigh Hospital
RECRUITING

Raleigh, North Carolina, 27609, United States
Duke University
RECRUITING

Durham, North Carolina, 27713, United States
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27710, United States
Duke University Medical Center (location of scans)
RECRUITING

Durham, North Carolina, 27710, United States
Duke University Medical Center - Duke University Hospital (location of scans)
RECRUITING

Durham, North Carolina, 27710, United States
Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)
RECRUITING

Raleigh, North Carolina, 27609, United States
Eastern Connecticut Hematology and Oncology Associates
RECRUITING

Norwich, Connecticut, 06360, United States
Eye Associates Northwest - Ballard Clinic and Surgery Center
RECRUITING

Seattle, Washington, 98104, United States
Eye Associates Northwest - Edmonds Clinic
RECRUITING

Edmonds, Washington, 98026, United States
Eye Associates Northwest - First Hill Clinic
RECRUITING

Seattle, Washington, 98104, United States
Eye Associates Northwest - Kirkland Clinic
RECRUITING

Kirkland, Washington, 98034, United States
Eye Associates Northwest - Northgate Clinic
RECRUITING

Seattle, Washington, 98125, United States
Fred Hutchinson Cancer Center
RECRUITING

Seattle, Washington, 98109, United States
Harborview Medical Center
RECRUITING

Seattle, Washington, 98104, United States
Highlands Oncology Group, PA
RECRUITING

Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group, PA
RECRUITING

Rogers, Arkansas, 72758, United States
Highlands Oncology Group, PA
RECRUITING

Springdale, Arkansas, 72762, United States
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
RECRUITING

Rio Piedras, 00935, Puerto Rico
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING

Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Marqués de Valdecilla
RECRUITING

Santander, Cantabria, 39008, Spain
Hospital Universitario Virgen Del Rocio
RECRUITING

Seville, 41013, Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, Catalunya [cataluña], 08041, Spain
Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States
Icon Cancer Centre Wesley
RECRUITING

Auchenflower, Queensland, 4066, Australia
Johns Hopkins Hospital
RECRUITING

Baltimore, Maryland, 21287, United States
Johns Hopkins Outpatient Center
RECRUITING

Baltimore, Maryland, 21287, United States
Keio university hospital
RECRUITING

Shinjuku-ku, Tokyo, 1608582, Japan
Macquarie University
RECRUITING

North Ryde, New South Wales, 2109, Australia
Memorial Hospital
RECRUITING

Shiloh, Illinois, 62269, United States
Monash Health
RECRUITING

Clayton, Victoria, 3168, Australia
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING

Nanjing, Jiangsu, 210000, China
National Hospital Organization Kyushu Cancer Center
RECRUITING

Fukuoka, 811-1395, Japan
New York Oncology Hematology
RECRUITING

Albany, New York, 12206, United States
New York Oncology Hematology
RECRUITING

Clifton Park, New York, 12065, United States
Northwest Cancer Specialists, P.C.
RECRUITING

Portland, Oregon, 97213, United States
Northwest Cancer Specialists, P.C.
RECRUITING

Portland, Oregon, 97227, United States
Northwest Cancer Specialists, P.C.
RECRUITING

Tigard, Oregon, 97223, United States
Northwest Cancer Specialists, P.C.
RECRUITING

Vancouver, Washington, 98684, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING

Blacksburg, Virginia, 24060, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING

Low Moor, Virginia, 24457, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING

Roanoke, Virginia, 24014, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING

Salem, Virginia, 24153, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING

Wytheville, Virginia, 24382, United States
Oncology Associates of Oregon, P.C.
RECRUITING

Eugene, Oregon, 97401, United States
Oncology Associates of Oregon, P.C.
RECRUITING

Springfield, Oregon, 97477, United States
Oncology Research Pharmacy and lnvestigational Drug Service
RECRUITING

Baltimore, Maryland, 21231, United States
Pan American Center for Oncology Trials, LLC
RECRUITING

Rio Piedras, 00935, Puerto Rico
Pan American Center for Oncology Trials, LLC - Manati Office
RECRUITING

Manati, 00674, Puerto Rico
Pan American Center for Oncology Trials, LLC - Mayaguez Office
RECRUITING

Mayagüez, 00680, Puerto Rico
Parc de Salut Mar - Hospital del Mar
RECRUITING

Barcelona, Barcelona [barcelona], 08003, Spain
Rocky Mountain Cancer Centers, LLP
RECRUITING

Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers, LLP
RECRUITING

Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, LLP
RECRUITING

Lone Tree, Colorado, 80124, United States
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute
RECRUITING

Nashville, Tennessee, 37203, United States
Sibley Memorial Hospital
RECRUITING

Washington D.C., District of Columbia, 20016, United States
Sibley Memorial Hospital Pharmacy Department
RECRUITING

Washington D.C., District of Columbia, 20016, United States
Siteman Cancer Center
RECRUITING

St Louis, Missouri, 63108, United States
Siteman Cancer Center - North County
RECRUITING

Florissant, Missouri, 63031, United States
Siteman Cancer Center - Shiloh
RECRUITING

Shiloh, Illinois, 62269, United States
Siteman Cancer Center - South County
RECRUITING

St Louis, Missouri, 63129, United States
Siteman Cancer Center - St. Peters
RECRUITING

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
RECRUITING

Creve Coeur, Missouri, 63141, United States
Tennessee Oncology, PLLC - Chattanooga Downtown
RECRUITING

Chattanooga, Tennessee, 37403, United States
Tennessee Oncology, PLLC - Chattanooga East
RECRUITING

Chattanooga, Tennessee, 37421, United States
Tennessee Oncology, PLLC - Chattanooga Med Park II
RECRUITING

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Chattanooga Memorial
RECRUITING

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Dickson
RECRUITING

Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology
RECRUITING

Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Franklin
RECRUITING

Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC - Gallatin
RECRUITING

Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC - Hendersonville
RECRUITING

Hendersonville, Tennessee, 37075, United States
Tennessee Oncology, PLLC - Investigational Drug Services
RECRUITING

Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
RECRUITING

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Lebanon
RECRUITING

Lebanon, Tennessee, 37090, United States
Tennessee Oncology, PLLC - Mount Juliet
RECRUITING

Mount Juliet, Tennessee, 37122, United States
Tennessee Oncology, PLLC - Murfreesboro
RECRUITING

Murfreesboro, Tennessee, 37129, United States
Tennessee Oncology, PLLC - Proton Center
RECRUITING

Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC - Saint Thomas West
RECRUITING

Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC - Smyrna
RECRUITING

Smyrna, Tennessee, 37167, United States
Tennessee Oncology, PLLC -Shelbyville
RECRUITING

Shelbyville, Tennessee, 37160, United States
Tennessee Oncology, PLLC- Cookeville
RECRUITING

Cookeville, Tennessee, 38501, United States
Tennessee Oncology, PLLC- Ringgold
RECRUITING

Ringgold, Georgia, 30736, United States
Tennessee Oncology, PLLC- Skyline
RECRUITING

Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC- Southern Hills
RECRUITING

Nashville, Tennessee, 37211, United States
Texas Oncology - Central South
RECRUITING

Austin, Texas, 78758, United States
Texas Oncology - Central/South Texas
RECRUITING

Austin, Texas, 78705, United States
Texas Oncology - Central/South Texas
RECRUITING

Austin, Texas, 78731, United States
Texas Oncology - Central/South Texas
RECRUITING

Austin, Texas, 78745, United States
Texas Oncology - Central/South Texas
RECRUITING

Harlingen, Texas, 78550, United States
Texas Oncology - Central/South Texas
RECRUITING

McAllen, Texas, 78503, United States
Texas Oncology - Central/South Texas
RECRUITING

Waco, Texas, 76712, United States
Texas Oncology - Gulf Coast
RECRUITING

Beaumont, Texas, 77702, United States
Texas Oncology - Gulf Coast
RECRUITING

Houston, Texas, 77024, United States
Texas Oncology - Gulf Coast
RECRUITING

Houston, Texas, 77054, United States
Texas Oncology - Gulf Coast
RECRUITING

Pearland, Texas, 77584, United States
Texas Oncology - Gulf Coast
RECRUITING

Sugar Land, Texas, 77479, United States
Texas Oncology - Gulf Coast
RECRUITING

The Woodlands, Texas, 77380, United States
Texas Oncology - Gulf Coast
RECRUITING

Webster, Texas, 77598, United States
The Second Hospital of Tianjin Medical University
RECRUITING

Tianjin, Tianjin Municipality, 300211, China
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITING

Baltimore, Maryland, 21231, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITING

Baltimore, Maryland, 21287, United States
The first affiliated hospital of Ningbo university
RECRUITING

Ningbo, Zhejiang, 315010, China
UC San Diego Koman Family Outpatient Pavilion
RECRUITING

La Jolla, California, 92037, United States
UC San Diego McGrath Outpatient Pavilion - Hillcrest
RECRUITING

San Diego, California, 92103, United States
UC San Diego Medical Center - Bankers Hill
RECRUITING

San Diego, California, 92101, United States
UC San Diego Medical Center - Encinitas
RECRUITING

Encinitas, California, 92024, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
RECRUITING

La Jolla, California, 92037, United States
UC San Diego Medical Center - Rancho Bernardo
RECRUITING

San Diego, California, 92127, United States
UC San Diego Medical Center - Vista
RECRUITING

Vista, California, 92081, United States
UC San Diego Medical Center- Hillcrest
RECRUITING

San Diego, California, 92103, United States
UC San Diego Moores Cancer Center
RECRUITING

La Jolla, California, 92037, United States
UC San Diego Shiley Eye Institute
RECRUITING

La Jolla, California, 92037, United States
UC San Diego Sulpizio Cardiovascular Center
RECRUITING

La Jolla, California, 92037, United States
UCLA Hematology Oncology - Porter Ranch
NOT_YET_RECRUITING

Porter Ranch, California, 91326, United States
UCLA Hematology Oncology- Laguna Hills
NOT_YET_RECRUITING

Laguna Hills, California, 92653, United States
UCLA Hematology/Oncology
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
UCLA Hematology/Oncology - Alhambra
NOT_YET_RECRUITING

Alhambra, California, 91801, United States
UCLA Hematology/Oncology - Atascadero
NOT_YET_RECRUITING

Atascadero, California, 93422, United States
UCLA Hematology/Oncology - Beverly Hills
NOT_YET_RECRUITING

Beverly Hills, California, 90212, United States
UCLA Hematology/Oncology - Burbank
NOT_YET_RECRUITING

Burbank, California, 91505, United States
UCLA Hematology/Oncology - Encino
NOT_YET_RECRUITING

Encino, California, 91436, United States
UCLA Hematology/Oncology - Irvine
NOT_YET_RECRUITING

Irvine, California, 92604, United States
UCLA Hematology/Oncology - Marina del Rey
NOT_YET_RECRUITING

Marina del Rey, California, 90292, United States
UCLA Hematology/Oncology - Pasadena
NOT_YET_RECRUITING

Pasadena, California, 91105, United States
UCLA Hematology/Oncology - San Luis Obispo
NOT_YET_RECRUITING

San Luis Obispo, California, 93401, United States
UCLA Hematology/Oncology - Santa Clarita
NOT_YET_RECRUITING

Valencia, California, 91355, United States
UCLA Hematology/Oncology - Torrance
NOT_YET_RECRUITING

Torrance, California, 90505, United States
UCLA Hematology/Oncology - Ventura
NOT_YET_RECRUITING

Ventura, California, 93003, United States
UCLA Hematology/Oncology - Westlake
NOT_YET_RECRUITING

Westlake Village, California, 91361, United States
UCLA Hematology/Oncology- Santa Barbara
NOT_YET_RECRUITING

Santa Barbara, California, 93101, United States
UCLA Hematology/Oncology- Santa Monica
NOT_YET_RECRUITING

Santa Monica, California, 90404, United States
US Oncology Investigational Product Center (IPC)
RECRUITING

Irving, Texas, 75063, United States
US Oncology Investigational Products Center (IPC)
RECRUITING

Irving, Texas, 75063, United States
University Hospitals Cleveland Medical Center
RECRUITING

Cleveland, Ohio, 44106, United States
University Of Washington Medical Center
RECRUITING

Seattle, Washington, 98195, United States
Virginia Cancer Specialists, PC
RECRUITING

Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
RECRUITING

Norfolk, Virginia, 23502, United States
Viterbi Family Department of Ophthalmology
RECRUITING

La Jolla, California, 92037, United States
Washington University School of Medicine - Siteman Cancer Center
RECRUITING

St Louis, Missouri, 63110, United States
Yamagata University Hospital
RECRUITING

Yamagata, 990-9585, Japan

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