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

Recruiting now · Phase 1

Conditions studied: Non-muscle Invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT07206225

Run by

Pfizer

People needed

294

Starts

2025-11-06

Expected to finish

2033-01-28

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• SUNY Upstate Medical University-Community Campus — Syracuse, New York, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• UAB Infusion Therapy Extended Care Clinic (ECC) — Birmingham, Alabama, United States (enrolling)
• SUNY Upstate Medical University — Syracuse, New York, United States (enrolling)
• The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Moffitt McKinley Hospital — Tampa, Florida, United States (enrolling)
• Moffitt Cancer Center at Wesley Chapel — Wesley Chapel, Florida, United States (enrolling)
• Moffitt Cancer Center at SouthShore — Ruskin, Florida, United States (enrolling)
• Upstate Specialty Services at Harrison Center — Syracuse, New York, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States (enrolling)
• The University of Alabama at Birmingham Investigation Drug Services Pharmacy — Birmingham, Alabama, United States (enrolling)
• University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
• The University of Kansas - Clinical Research Center — Fairway, Kansas, United States (enrolling)
• The University of Kansas Hospital Cambridge North Tower A — Kansas City, Kansas, United States (enrolling)
• The University of Kansas Hospital — Kansas City, Kansas, United States (enrolling)
• The University of Kansas Medical Center Medical Office Building — Kansas City, Kansas, United States (enrolling)
• The University of Kansas Hospital - Indian Creek Campus — Overland Park, Kansas, United States (enrolling)
• The University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States (enrolling)
• Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• Moffitt Cancer Center - International Plaza — Tampa, Florida, United States (enrolling)
• Biorepository and Precision Pathology Center (BRPC) — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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