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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07206225

Registry updated: 2026-10-13
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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. 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.

Interventions

  • PF-08052667 (Drug)
    PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash
  • Sasanlimab (Drug)
    Sasanlimab will be administered as subcutaneous (SC) injection
  • BCG (Drug)
    BCG will be administered intravesical (IVe) instillation
  • PF-02921367 (Drug)
    PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation

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

Conditions

Non-muscle Invasive Bladder Cancer

Locations

  • The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States
  • UAB Infusion Therapy Extended Care Clinic (ECC) — Birmingham, Alabama, United States
  • The University of Alabama at Birmingham Investigation Drug Services Pharmacy — Birmingham, Alabama, United States
  • University of Alabama at Birmingham — Birmingham, Alabama, United States
  • Moffitt Cancer Center at SouthShore — Ruskin, Florida, United States
  • Moffitt Cancer Center - International Plaza — Tampa, Florida, United States
  • Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States
  • Moffitt Cancer Center — Tampa, Florida, United States
  • Moffitt McKinley Hospital — Tampa, Florida, United States
  • Moffitt Cancer Center at Wesley Chapel — Wesley Chapel, Florida, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Emory University Hospital — Atlanta, Georgia, United States
  • Emory University — Atlanta, Georgia, United States
  • Northwestern Memorial Hospital — Chicago, Illinois, United States
  • Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States
  • University of Iowa Health Care — Iowa City, Iowa, United States
  • The University of Kansas - Clinical Research Center — Fairway, Kansas, United States
  • The University of Kansas Hospital Cambridge North Tower A — Kansas City, Kansas, United States
  • The University of Kansas Hospital — Kansas City, Kansas, United States
  • The University of Kansas Medical Center Medical Office Building — Kansas City, Kansas, United States
  • The University of Kansas Hospital - Indian Creek Campus — Overland Park, Kansas, United States
  • The University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States
  • MSK Basking Ridge — Basking Ridge, New Jersey, United States
  • MSK Monmouth — Middletown, New Jersey, United States
  • MSK Bergen — Montvale, New Jersey, United States
  • MSK Commack — Commack, New York, United States
  • MSK Westchester — Harrison, New York, United States
  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center 53rd street — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
  • 64th Street Outpatient and Innovation Center — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center - Main Campus — New York, New York, United States
  • Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Upstate Specialty Services at Harrison Center — Syracuse, New York, United States
  • SUNY Upstate Medical University — Syracuse, New York, United States
  • SUNY Upstate Medical University-Community Campus — Syracuse, New York, United States
  • MSK Nassau — Uniondale, New York, United States
  • Biorepository and Precision Pathology Center (BRPC) — Durham, North Carolina, United States
  • Duke Cancer Institute — Durham, North Carolina, United States
  • Substrate Services Core Research Support (SSCRS) — Durham, North Carolina, United States
  • Grand Strand Medical Center — Myrtle Beach, South Carolina, United States
  • AUC Urologists, LLC — Myrtle Beach, South Carolina, United States
  • Carolina Urologic Research Center, LLC — Myrtle Beach, South Carolina, United States
  • Parkway Surgery Center — Myrtle Beach, South Carolina, United States
  • Coastal Eye Group — Myrtle Beach, South Carolina, United States
  • Urology Associates, P.C. — Nashville, Tennessee, United States
  • Cancer Center Outpatient Building — Dallas, Texas, United States
  • The University of Texas Southwestern Medical Center — Dallas, Texas, United States
  • UT Southwestern Medical Center - West Campus Building — Dallas, Texas, United States
  • UT Southwestern Medical Center - William P Clements Jr University Hospital — Dallas, Texas, United States
  • UT Southwestern Medical Center-William P. Clements Imaging Center — Dallas, Texas, United States
  • Baptist M&S Imaging (Medical Center) — San Antonio, Texas, United States
  • USA Clinical Trials — San Antonio, Texas, United States
  • MCOA Eye Associates — San Antonio, Texas, United States
  • Gustave Roussy — Villejuif, VAL DE Marne, France
  • Pitie Salpetriere University Hospital — Paris, France
  • Rabin Medical Center — Petah Tikva, Central District, Israel
  • Sheba Medical Center — Ramat Gan, Central District, Israel
  • Hadassah Medical Center — Jerusalem, Jerusalem, Israel
  • Rambam Health Care Campus — Haifa, Northern District, Israel
  • Samsung Medical Center — Seoul, Seoul Teukbyeolsi [seoul], South Korea
  • Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, Seoul-teukbyeolsi, South Korea
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, England, United Kingdom
  • Royal Hallamshire Hospital — Sheffield, South Yorkshire, United Kingdom
  • The University of Sheffield — Sheffield, United Kingdom
  • Weston Park Cancer Centre — Sheffield, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record