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NCT07206225RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
294 (estimated)
First submitted
25 Sept 2025
Start date
6 Nov 2025
Primary completion date
29 Jan 2030
Lead sponsor
Pfizer
NCT number
NCT07206225
EU CT number
2025-521756-39-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 294
  • From 6 Nov 2025 to the primary completion date, 29 Jan 2030
  • 71 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed

Other illness

  • Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol
  • Participants with active, uncontrolled infection as specified in the protocol

Who the study is looking for

  • 18 years of age or older (or the minimum age of consent per local regulations)
  • 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
  • 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.
  • Have refused or are ineligible or not appropriate for radical cystectomy
  • 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
  • ECOG PS 0 or 1

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (71)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundació Puigvert
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Weston Park Cancer Centre
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SheffieldUnited KingdomRecruiting
Royal Hallamshire Hospital
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SheffieldUnited KingdomRecruiting
Sheffield Teaching Hospitals NHS Foundation Trust
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SheffieldUnited KingdomRecruiting
The University of Sheffield
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SheffieldUnited KingdomRecruiting
Rambam Health Care Campus
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HaifaIsraelNot yet recruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Emory University Hospital Midtown
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AtlantaUnited StatesRecruiting
Emory University Hospital
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AtlantaUnited StatesRecruiting
Emory University
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AtlantaUnited StatesRecruiting
Emory Children's Center
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AtlantaUnited StatesRecruiting
MSK Basking Ridge.
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Basking RidgeUnited StatesRecruiting
UAB Infusion Therapy Extended Care Clinic (ECC)
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BirminghamUnited StatesRecruiting
University of Alabama at Birmingham
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BirminghamUnited StatesRecruiting
The University of Alabama at Birmingham Investigation Drug Services Pharmacy
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BirminghamUnited StatesRecruiting
The Kirklin Clinic of UAB Hospital
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BirminghamUnited StatesRecruiting
Northwestern Memorial Hospital
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ChicagoUnited StatesNot yet recruiting
Northwestern University Feinberg School of Medicine
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ChicagoUnited StatesNot yet recruiting
MSK Commack.
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CommackUnited StatesRecruiting
The University of Texas Southwestern Medical Center
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DallasUnited StatesRecruiting
UT Southwestern Medical Center-William P. Clements Imaging Center
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DallasUnited StatesRecruiting
Cancer Center Outpatient Building
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DallasUnited StatesRecruiting
UT Southwestern Medical Center - West Campus Building
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DallasUnited StatesRecruiting
UT Southwestern Medical Center - William P Clements Jr University Hospital
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DallasUnited StatesRecruiting
Substrate Services Core Research Support (SSCRS)
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DurhamUnited StatesRecruiting
Biorepository and Precision Pathology Center (BRPC)
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DurhamUnited StatesRecruiting
Duke Cancer Institute
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DurhamUnited StatesRecruiting
The University of Kansas - Clinical Research Center
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FairwayUnited StatesRecruiting
MSK Westchester.
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HarrisonUnited StatesRecruiting
University of Iowa Health Care
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Iowa CityUnited StatesRecruiting
The University of Kansas Hospital Cambridge North Tower A
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Kansas CityUnited StatesRecruiting
The University of Kansas Hospital
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Kansas CityUnited StatesRecruiting
The University of Kansas Medical Center Medical Office Building
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Kansas CityUnited StatesRecruiting
MSK Monmouth.
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MiddletownUnited StatesRecruiting
MSK Bergen.
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MontvaleUnited StatesRecruiting
Parkway Surgery Center
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Myrtle BeachUnited StatesRecruiting
Coastal Eye Group
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Myrtle BeachUnited StatesRecruiting
AUC Urologists, LLC
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Myrtle BeachUnited StatesRecruiting
Carolina Urologic Research Center, LLC
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Myrtle BeachUnited StatesRecruiting
Grand Strand Medical Center
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Myrtle BeachUnited StatesRecruiting
Urology Associates, P.C.
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NashvilleUnited StatesRecruiting
64th Street Outpatient and Innovation Center
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New YorkUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center 53rd street.
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New YorkUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - Main Campus
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New YorkUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
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New YorkUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesRecruiting
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
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New YorkUnited StatesRecruiting
The University of Kansas Hospital - Indian Creek Campus
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Overland ParkUnited StatesRecruiting
Moffitt Cancer Center at SouthShore
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RuskinUnited StatesRecruiting
MCOA Eye Associates
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San AntonioUnited StatesRecruiting
Baptist M&S Imaging (Medical Center)
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San AntonioUnited StatesRecruiting
USA Clinical Trials
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San AntonioUnited StatesRecruiting
SUNY Upstate Medical University-Community Campus
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SyracuseUnited StatesRecruiting
SUNY Upstate Medical University
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SyracuseUnited StatesRecruiting
Upstate Specialty Services at Harrison Center
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SyracuseUnited StatesRecruiting
Moffitt Cancer Center - McKinley Campus
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TampaUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesRecruiting
Moffitt Cancer Center-International Plaza
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TampaUnited StatesRecruiting
Moffitt McKinley Hospital
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TampaUnited StatesRecruiting
MSK Nassau.
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UniondaleUnited StatesRecruiting
Moffitt Cancer Center at Wesley Chapel
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Wesley ChapelUnited StatesRecruiting
The University of Kansas Cancer Center - Westwood
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WestwoodUnited StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.