A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Start Date
11/6/2025
Completion Date
1/28/2033
Summary
The purpose of this study is to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and/or a medicine called sasanlimab. This study is for adults who have a type of bladder cancer that hasn't spread into the muscle layer of the bladder but is more likely to come back or grow. It includes people whose cancer has come back or hasn't gone away after receiving standard treatments like BCG. It may also include people who, based on their doctor's opinion, cannot receive standard treatments or those treatments are not available to them. The study has three parts: * Part 1 (monotherapy dose escalation) will test PF-08052667 as a single-agent at increasing dose levels in participants with certain bladder cancer whose disease has worsened on or after standard treatments. * Part 2 (combination dose escalation) will test PF-08052667 in combination with BCG and/or sasanlimab (fixed dose) in participants with certain bladder cancer whose disease has worsened on or after standard treatments. * Part 3 (dose optimization and expansion) will further test PF-08052667 as a single agent or in combination with BCG and/or sasanlimab, at the dose(s) based on findings from Part 1 and Part 2 in participants with certain bladder cancer including those who has never received standard treatments. All participants will receive the study drug PF-08052667. Only participants in Part 2 and Part 3 of the study will also receive BCG and/or sasanlimab. PF-08052667 will be given as an intravesical infusion, which means it will be injected directly into the bladder. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin. For all parts, treatment with study medicines will continue until either a participant has decided to stop taking part in the study or is asked to leave the study for various reasons or up to about 2 years, whichever occurs first. Duration of trial participation for each participant will vary as long-term follow-up will continue after treatment discontinuation until loss to-follow-up or death, or until the study is stopped by the sponsor.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PF-08052667
Sasanlimab
BCG
PF-02921367
Conditions
Locations
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama 35233
United States
UAB Infusion Therapy Extended Care Clinic (ECC)
Birmingham, Alabama 35233
United States
The University of Alabama at Birmingham Investigation Drug Services Pharmacy
Birmingham, Alabama 35249
United States
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Moffitt Cancer Center at SouthShore
Ruskin, Florida 33570
United States
Moffitt Cancer Center - International Plaza
Tampa, Florida 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Moffitt McKinley Hospital
Tampa, Florida 33612
United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida 33544
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Emory University Hospital
Atlanta, Georgia 30322
United States
Emory University
Atlanta, Georgia 30322
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois 60611
United States
University of Iowa Health Care
Iowa City, Iowa 52242
United States
The University of Kansas - Clinical Research Center
Fairway, Kansas 66205
United States
The University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas 66160
United States
The University of Kansas Hospital
Kansas City, Kansas 66160
United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas 66160
United States
The University of Kansas Hospital - Indian Creek Campus
Overland Park, Kansas 66211
United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
United States
MSK Basking Ridge
Basking Ridge, New Jersey 07920
United States
MSK Monmouth
Middletown, New Jersey 07748
United States
MSK Bergen
Montvale, New Jersey 07645
United States
MSK Commack
Commack, New York 11725
United States
MSK Westchester
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York 10021
United States
Memorial Sloan Kettering Cancer Center 53rd street
New York, New York 10022
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
64th Street Outpatient and Innovation Center
New York, New York 10065
United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York 10065
United States
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Upstate Specialty Services at Harrison Center
Syracuse, New York 13202
United States
SUNY Upstate Medical University
Syracuse, New York 13210
United States
SUNY Upstate Medical University-Community Campus
Syracuse, New York 13215
United States
MSK Nassau
Uniondale, New York 11553
United States
Biorepository and Precision Pathology Center (BRPC)
Durham, North Carolina 27710
United States
Duke Cancer Institute
Durham, North Carolina 27710
United States
Substrate Services Core Research Support (SSCRS)
Durham, North Carolina 27710
United States
Grand Strand Medical Center
Myrtle Beach, South Carolina 295724607
United States
AUC Urologists, LLC
Myrtle Beach, South Carolina 29572
United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572
United States
Parkway Surgery Center
Myrtle Beach, South Carolina 29572
United States
Coastal Eye Group
Myrtle Beach, South Carolina 29579
United States
Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Cancer Center Outpatient Building
Dallas, Texas 75235
United States
The University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
UT Southwestern Medical Center - West Campus Building
Dallas, Texas 75390
United States
UT Southwestern Medical Center - William P Clements Jr University Hospital
Dallas, Texas 75390
United States
UT Southwestern Medical Center-William P. Clements Imaging Center
Dallas, Texas 75390
United States
Baptist M&S Imaging (Medical Center)
San Antonio, Texas 78229
United States
USA Clinical Trials
San Antonio, Texas 78229
United States
MCOA Eye Associates
San Antonio, Texas 78240
United States
Gustave Roussy
Villejuif, VAL DE Marne 94800
France
Pitie Salpetriere University Hospital
Paris, 75013
France
Rabin Medical Center
Petah Tikva, Central District 4941492
Israel
Sheba Medical Center
Ramat Gan, Central District 5265601
Israel
Hadassah Medical Center
Jerusalem, Jerusalem 9112001
Israel
Rambam Health Care Campus
Haifa, Northern District 3109601
Israel
Samsung Medical Center
Seoul, Seoul Teukbyeolsi [seoul] 06351
South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi 03722
South Korea
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, England S10 2SJ
United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire S10 2JF
United Kingdom
The University of Sheffield
Sheffield, S10 2RX
United Kingdom
Weston Park Cancer Centre
Sheffield, S10 2SJ
United Kingdom