NCT07206225From ClinicalTrials.govRecruiting

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

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052667 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH BLADDER CANCER

Non-muscle Invasive Bladder Cancer

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 294
Started: 6 November 2025
Main results due: 29 January 2030
Study sites: 68
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(68)

The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
Recruiting
UAB Infusion Therapy Extended Care Clinic (ECC)
Birmingham, Alabama, United States
Recruiting
The University of Alabama at Birmingham Investigation Drug Services Pharmacy
Birmingham, Alabama, United States
Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States
Recruiting
Moffitt Cancer Center - International Plaza
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Moffitt McKinley Hospital
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Recruiting
Emory University Hospital
Atlanta, Georgia, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, United States
Not yet recruiting
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
Not yet recruiting
University of Iowa Health Care
Iowa City, Iowa, United States
Recruiting
The University of Kansas - Clinical Research Center
Fairway, Kansas, United States
Recruiting
The University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, United States
Recruiting
The University of Kansas Hospital
Kansas City, Kansas, United States
Recruiting
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, United States
Recruiting
The University of Kansas Hospital - Indian Creek Campus
Overland Park, Kansas, United States
Recruiting
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
Recruiting
MSK Basking Ridge
Basking Ridge, New Jersey, United States
Recruiting
MSK Monmouth
Middletown, New Jersey, United States
Recruiting
MSK Bergen
Montvale, New Jersey, United States
Recruiting
MSK Commack
Commack, New York, United States
Recruiting
MSK Westchester
Harrison, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center 53rd street
New York, New York, United States
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Recruiting
64th Street Outpatient and Innovation Center
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
Recruiting
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Upstate Specialty Services at Harrison Center
Syracuse, New York, United States
Recruiting
SUNY Upstate Medical University
Syracuse, New York, United States
Recruiting
SUNY Upstate Medical University-Community Campus
Syracuse, New York, United States
Recruiting
MSK Nassau
Uniondale, New York, United States
Recruiting
Biorepository and Precision Pathology Center (BRPC)
Durham, North Carolina, United States
Recruiting
Duke Cancer Institute
Durham, North Carolina, United States
Recruiting
Substrate Services Core Research Support (SSCRS)
Durham, North Carolina, United States
Recruiting
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States
Recruiting
AUC Urologists, LLC
Myrtle Beach, South Carolina, United States
Recruiting
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
Recruiting
Parkway Surgery Center
Myrtle Beach, South Carolina, United States
Recruiting
Coastal Eye Group
Myrtle Beach, South Carolina, United States
Recruiting
Urology Associates, P.C.
Nashville, Tennessee, United States
Recruiting
Cancer Center Outpatient Building
Dallas, Texas, United States
Recruiting
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Recruiting
UT Southwestern Medical Center - West Campus Building
Dallas, Texas, United States
Recruiting
UT Southwestern Medical Center - William P Clements Jr University Hospital
Dallas, Texas, United States
Recruiting
UT Southwestern Medical Center-William P. Clements Imaging Center
Dallas, Texas, United States
Recruiting
Baptist M&S Imaging (Medical Center)
San Antonio, Texas, United States
Recruiting
USA Clinical Trials
San Antonio, Texas, United States
Recruiting
MCOA Eye Associates
San Antonio, Texas, United States
Recruiting
Gustave Roussy
Villejuif, VAL DE Marne, France
Recruiting
Pitie Salpetriere University Hospital
Paris, France
Recruiting
Rabin Medical Center
Petah Tikva, Central District, Israel
Recruiting
Sheba Medical Center
Ramat Gan, Central District, Israel
Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Recruiting
Rambam Health Care Campus
Haifa, Northern District, Israel
Not yet recruiting

Showing 60 of 68 sites — filter to narrow it down. 65 of the 68 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07206225. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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