Status:
RECRUITING
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Lead Sponsor:
Pfizer
Conditions:
Non-muscle Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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 CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
November 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 28 2033
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT07206225
Start Date
November 6 2025
End Date
January 28 2033
Last Update
December 16 2025
Active Locations (38)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
UCLA Hematology/Oncology - Westwood (Building 300)
Los Angeles, California, United States, 90095
3
AdventHealth Orlando
Orlando, Florida, United States, 32803
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612