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NCT07206225PHASE1Recruiting

A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer

Pfizer

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

INCLUSION CRITERIA: 1. 18 years of age or older (or the minimum age of consent per local regulations) 2. Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder defined according to the WHO grading system as carcinoma in situ (CIS), with or without concurrent T1/Ta papillary disease. Note: High-grade T1/Ta papillary disease, in the absence of CIS, may be eligible for certain cohorts in Part 2 and 3 3. BCG unresponsive and BCG-exposed cohorts should have persistent or recurrent disease after receiving at least 5 out of 6 doses of the BCG induction therapy. 4. Have refused or are ineligible or not appropriate for radical cystectomy 5. Tissue Requirement: Available tumor tissue within the last 6 months. On-treatment tumor biopsy is optional, unless mandated based on emerging data, or participating in the Biomarker Cohort, or for disease assessment 6. ECOG PS 0 or 1 EXCLUSION CRITERIA: 1. Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed 2. Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol 3. Participants with active, uncontrolled infection as specified in the protocol

Interventions

DRUG

PF-08052667

DRUG

Sasanlimab

DRUG

BCG

DRUG

PF-02921367

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Conditions

Non-muscle Invasive Bladder Cancer

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