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Taking people in United StatesPhase 1

Tests PF-08052667 alone or with BCG or sasanlimab in bladder cancer

Tests a new medicine, PF-08052667, in adults with non-muscle invasive bladder cancer.

Plain-language title generated from the registry record
Registry title: A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer

Key facts

Where
Atlanta, Basking Ridge, Birmingham, Chicago, Commack, Dallas, Durham, Fairway, Harrison, Iowa City, Kansas City, Middletown, Montvale, Myrtle Beach, Nashville, New York, Overland Park, Ruskin, San Antonio, Syracuse, Tampa, Uniondale, Wesley Chapel, and Westwood, United StatesSee the 55 sites
Phase
Phase 1

Where in United States

  • Emory Children's CenterAtlanta, United StatesTaking people
  • Emory UniversityAtlanta, United StatesTaking people
  • Emory University HospitalAtlanta, United StatesTaking people
  • Emory University Hospital MidtownAtlanta, United StatesTaking people
  • MSK Basking Ridge.Basking Ridge, United StatesTaking people
  • The Kirklin Clinic of UAB HospitalBirmingham, United StatesTaking people
  • The University of Alabama at Birmingham Investigation Drug Services PharmacyBirmingham, United StatesTaking people
  • UAB Infusion Therapy Extended Care Clinic (ECC)Birmingham, United StatesTaking people
  • University of Alabama at BirminghamBirmingham, United StatesTaking people
  • Northwestern Memorial HospitalChicago, United StatesNot yet recruiting
  • Northwestern University Feinberg School of MedicineChicago, United StatesNot yet recruiting
  • MSK Commack.Commack, United StatesTaking people
  • Cancer Center Outpatient BuildingDallas, United StatesTaking people
  • The University of Texas Southwestern Medical CenterDallas, United StatesTaking people
  • UT Southwestern Medical Center - West Campus BuildingDallas, United StatesTaking people
  • UT Southwestern Medical Center - William P Clements Jr University HospitalDallas, United StatesTaking people
  • UT Southwestern Medical Center-William P. Clements Imaging CenterDallas, United StatesTaking people
  • Biorepository and Precision Pathology Center (BRPC)Durham, United StatesTaking people
  • Duke Cancer InstituteDurham, United StatesTaking people
  • Substrate Services Core Research Support (SSCRS)Durham, United StatesTaking people
  • The University of Kansas - Clinical Research CenterFairway, United StatesTaking people
  • MSK Westchester.Harrison, United StatesTaking people
  • University of Iowa Health CareIowa City, United StatesTaking people
  • The University of Kansas HospitalKansas City, United StatesTaking people
  • The University of Kansas Hospital Cambridge North Tower AKansas City, United StatesTaking people
  • The University of Kansas Medical Center Medical Office BuildingKansas City, United StatesTaking people
  • MSK Monmouth.Middletown, United StatesTaking people
  • MSK Bergen.Montvale, United StatesTaking people
  • AUC Urologists, LLCMyrtle Beach, United StatesTaking people
  • Carolina Urologic Research Center, LLCMyrtle Beach, United StatesTaking people
  • Coastal Eye GroupMyrtle Beach, United StatesTaking people
  • Grand Strand Medical CenterMyrtle Beach, United StatesTaking people
  • Parkway Surgery CenterMyrtle Beach, United StatesTaking people
  • Urology Associates, P.C.Nashville, United StatesTaking people
  • 64th Street Outpatient and Innovation CenterNew York, United StatesTaking people
  • Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).New York, United StatesTaking people
  • Memorial Sloan Kettering Cancer Center - Main CampusNew York, United StatesTaking people
  • Memorial Sloan Kettering Cancer Center 53rd street.New York, United StatesTaking people
  • Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer CenterNew York, United StatesTaking people
  • The University of Kansas Hospital - Indian Creek CampusOverland Park, United StatesTaking people
  • Moffitt Cancer Center at SouthShoreRuskin, United StatesTaking people
  • Baptist M&S Imaging (Medical Center)San Antonio, United StatesTaking people
  • MCOA Eye AssociatesSan Antonio, United StatesTaking people
  • USA Clinical TrialsSan Antonio, United StatesTaking people
  • SUNY Upstate Medical UniversitySyracuse, United StatesTaking people
  • SUNY Upstate Medical University-Community CampusSyracuse, United StatesTaking people
  • Upstate Specialty Services at Harrison CenterSyracuse, United StatesTaking people
  • Moffitt Cancer CenterTampa, United StatesTaking people
  • Moffitt Cancer Center - McKinley CampusTampa, United StatesTaking people
  • Moffitt Cancer Center-International PlazaTampa, United StatesTaking people
  • Moffitt McKinley HospitalTampa, United StatesTaking people
  • MSK Nassau.Uniondale, United StatesTaking people
  • Moffitt Cancer Center at Wesley ChapelWesley Chapel, United StatesTaking people
  • The University of Kansas Cancer Center - WestwoodWestwood, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Pfizer
Trial code
NCT07206225EU 2025-521756-39-00
Record updated
5 November 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed; Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol; Participants with active, uncontrolled infection as specified in the protocol.

ClinicalTrials.gov NCT07206225 · EU CTIS 2025-521756-39-00