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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

Status: Recruiting
Location: See all (153) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Highlands Oncology Group, PA
RECRUITING
Fayetteville
Highlands Oncology Group, PA
RECRUITING
Rogers
Highlands Oncology Group, PA
RECRUITING
Springdale
California
UCLA Hematology/Oncology - Alhambra
NOT_YET_RECRUITING
Alhambra
UCLA Hematology/Oncology - Atascadero
NOT_YET_RECRUITING
Atascadero
UCLA Hematology/Oncology - Beverly Hills
NOT_YET_RECRUITING
Beverly Hills
UCLA Hematology/Oncology - Burbank
NOT_YET_RECRUITING
Burbank
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
RECRUITING
Duarte
City of Hope Investigational Drug Services (IDS)
RECRUITING
Duarte
UC San Diego Medical Center - Encinitas
RECRUITING
Encinitas
UCLA Hematology/Oncology - Encino
NOT_YET_RECRUITING
Encino
City of Hope at Irvine Lennar
RECRUITING
Irvine
City of Hope Investigational Drug Service (IDS)
RECRUITING
Irvine
UCLA Hematology/Oncology - Irvine
NOT_YET_RECRUITING
Irvine
UC San Diego Koman Family Outpatient Pavilion
RECRUITING
La Jolla
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
RECRUITING
La Jolla
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
UC San Diego Shiley Eye Institute
RECRUITING
La Jolla
UC San Diego Sulpizio Cardiovascular Center
RECRUITING
La Jolla
Viterbi Family Department of Ophthalmology
RECRUITING
La Jolla
UCLA Hematology Oncology- Laguna Hills
NOT_YET_RECRUITING
Laguna Hills
City of Hope-Long Beach (ELM)
RECRUITING
Long Beach
(IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center
NOT_YET_RECRUITING
Los Angeles
UCLA Hematology/Oncology
NOT_YET_RECRUITING
Los Angeles
UCLA Hematology/Oncology - Marina del Rey
NOT_YET_RECRUITING
Marina Del Rey
UCLA Hematology/Oncology - Pasadena
NOT_YET_RECRUITING
Pasadena
UCLA Hematology Oncology - Porter Ranch
NOT_YET_RECRUITING
Porter Ranch
UC San Diego McGrath Outpatient Pavilion - Hillcrest
RECRUITING
San Diego
UC San Diego Medical Center - Bankers Hill
RECRUITING
San Diego
UC San Diego Medical Center - Rancho Bernardo
RECRUITING
San Diego
UC San Diego Medical Center- Hillcrest
RECRUITING
San Diego
UCLA Hematology/Oncology - San Luis Obispo
NOT_YET_RECRUITING
San Luis Obispo
UCLA Hematology/Oncology- Santa Barbara
NOT_YET_RECRUITING
Santa Barbara
UCLA Hematology/Oncology- Santa Monica
NOT_YET_RECRUITING
Santa Monica
UCLA Hematology/Oncology - Torrance
NOT_YET_RECRUITING
Torrance
City of Hope UPLAND
RECRUITING
Upland
UCLA Hematology/Oncology - Santa Clarita
NOT_YET_RECRUITING
Valencia
UCLA Hematology/Oncology - Ventura
NOT_YET_RECRUITING
Ventura
UC San Diego Medical Center - Vista
RECRUITING
Vista
UCLA Hematology/Oncology - Westlake
NOT_YET_RECRUITING
Westlake Village
Colorado
Rocky Mountain Cancer Centers, LLP
RECRUITING
Aurora
Rocky Mountain Cancer Centers, LLP
RECRUITING
Denver
Rocky Mountain Cancer Centers, LLP
RECRUITING
Lone Tree
Connecticut
Eastern Connecticut Hematology and Oncology Associates
RECRUITING
Norwich
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Sibley Memorial Hospital Pharmacy Department
RECRUITING
Washington D.c.
Georgia
Tennessee Oncology, PLLC- Ringgold
RECRUITING
Ringgold
Illinois
Memorial Hospital
RECRUITING
Shiloh
Siteman Cancer Center - Shiloh
RECRUITING
Shiloh
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Johns Hopkins Outpatient Center
RECRUITING
Baltimore
Oncology Research Pharmacy and lnvestigational Drug Service
RECRUITING
Baltimore
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITING
Baltimore
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITING
Baltimore
Missouri
Siteman Cancer Center - St. Peters
RECRUITING
City Of Saint Peters
Siteman Cancer Center - West County
RECRUITING
Creve Coeur
Siteman Cancer Center - North County
RECRUITING
Florissant
Barnes-Jewish Hospital
RECRUITING
St Louis
Siteman Cancer Center
RECRUITING
St Louis
Siteman Cancer Center - South County
RECRUITING
St Louis
Washington University School of Medicine - Siteman Cancer Center
RECRUITING
St Louis
North Carolina
Duke Cancer Center Cary
RECRUITING
Cary
Duke University
RECRUITING
Durham
Duke University Medical Center
RECRUITING
Durham
Duke University Medical Center - Duke University Hospital (location of scans)
RECRUITING
Durham
Duke University Medical Center (location of scans)
RECRUITING
Durham
Duke Cancer Center Raleigh
RECRUITING
Raleigh
Duke Raleigh Hospital
RECRUITING
Raleigh
Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)
RECRUITING
Raleigh
New York
New York Oncology Hematology
RECRUITING
Albany
New York Oncology Hematology
RECRUITING
Clifton Park
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Oregon
Oncology Associates of Oregon, P.C.
RECRUITING
Eugene
Northwest Cancer Specialists, P.C.
RECRUITING
Portland
Northwest Cancer Specialists, P.C.
RECRUITING
Portland
Oncology Associates of Oregon, P.C.
RECRUITING
Springfield
Northwest Cancer Specialists, P.C.
RECRUITING
Tigard
Tennessee
Tennessee Oncology, PLLC - Chattanooga Downtown
RECRUITING
Chattanooga
Tennessee Oncology, PLLC - Chattanooga East
RECRUITING
Chattanooga
Tennessee Oncology, PLLC - Chattanooga Med Park II
RECRUITING
Chattanooga
Tennessee Oncology, PLLC - Chattanooga Memorial
RECRUITING
Chattanooga
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
RECRUITING
Chattanooga
Tennessee Oncology, PLLC- Cookeville
RECRUITING
Cookeville
Tennessee Oncology, PLLC - Dickson
RECRUITING
Dickson
Tennessee Oncology, PLLC - Franklin
RECRUITING
Franklin
Tennessee Oncology, PLLC - Proton Center
RECRUITING
Franklin
Tennessee Oncology, PLLC - Gallatin
RECRUITING
Gallatin
Tennessee Oncology, PLLC - Hendersonville
RECRUITING
Hendersonville
Tennessee Oncology, PLLC - Lebanon
RECRUITING
Lebanon
Tennessee Oncology, PLLC - Mount Juliet
RECRUITING
Mount Juliet
Tennessee Oncology, PLLC - Murfreesboro
RECRUITING
Murfreesboro
Sarah Cannon Research Institute
RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology
RECRUITING
Nashville
Tennessee Oncology, PLLC - Investigational Drug Services
RECRUITING
Nashville
Tennessee Oncology, PLLC - Saint Thomas West
RECRUITING
Nashville
Tennessee Oncology, PLLC- Skyline
RECRUITING
Nashville
Tennessee Oncology, PLLC- Southern Hills
RECRUITING
Nashville
Tennessee Oncology, PLLC -Shelbyville
RECRUITING
Shelbyville
Tennessee Oncology, PLLC - Smyrna
RECRUITING
Smyrna
Texas
Texas Oncology - Central South
RECRUITING
Austin
Texas Oncology - Central/South Texas
RECRUITING
Austin
Texas Oncology - Central/South Texas
RECRUITING
Austin
Texas Oncology - Central/South Texas
RECRUITING
Austin
Texas Oncology - Gulf Coast
RECRUITING
Beaumont
Texas Oncology - Central/South Texas
RECRUITING
Harlingen
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Houston
US Oncology Investigational Product Center (IPC)
RECRUITING
Irving
US Oncology Investigational Products Center (IPC)
RECRUITING
Irving
Texas Oncology - Central/South Texas
RECRUITING
Mcallen
Texas Oncology - Gulf Coast
RECRUITING
Pearland
Texas Oncology - Gulf Coast
RECRUITING
Sugar Land
Texas Oncology - Gulf Coast
RECRUITING
The Woodlands
Texas Oncology - Central/South Texas
RECRUITING
Waco
Texas Oncology - Gulf Coast
RECRUITING
Webster
Virginia
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Blacksburg
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Low Moor
Virginia Oncology Associates
RECRUITING
Norfolk
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Roanoke
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Salem
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Wytheville
Washington
Eye Associates Northwest - Edmonds Clinic
RECRUITING
Edmonds
Eye Associates Northwest - Kirkland Clinic
RECRUITING
Kirkland
Eye Associates Northwest - Ballard Clinic and Surgery Center
RECRUITING
Seattle
Eye Associates Northwest - First Hill Clinic
RECRUITING
Seattle
Eye Associates Northwest - Northgate Clinic
RECRUITING
Seattle
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Harborview Medical Center
RECRUITING
Seattle
University Of Washington Medical Center
RECRUITING
Seattle
Northwest Cancer Specialists, P.C.
RECRUITING
Vancouver
Other Locations
Australia
Icon Cancer Centre Wesley
RECRUITING
Auchenflower
Monash Health
RECRUITING
Clayton
Macquarie University
RECRUITING
North Ryde
China
Beijing Cancer hospital
RECRUITING
Beijing
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
The first affiliated hospital of Ningbo university
RECRUITING
Ningbo
The Second Hospital of Tianjin Medical University
RECRUITING
Tianjin
Japan
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Keio university hospital
RECRUITING
Shinjuku-ku
Yamagata University Hospital
RECRUITING
Yamagata
Puerto Rico
Pan American Center for Oncology Trials, LLC - Manati Office
RECRUITING
Manati
Pan American Center for Oncology Trials, LLC - Mayaguez Office
RECRUITING
Mayagüez
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
RECRUITING
Rio Piedras
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Parc de Salut Mar - Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-03-11
Estimated Completion Date: 2028-09-05
Participants
Target number of participants: 132
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Astellas Pharma Inc
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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