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
1 other identifier
interventional
294
5 countries
47
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2025
Longer than P75 for phase_1
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2025
CompletedFirst Posted
Study publicly available on registry
October 3, 2025
CompletedStudy Start
First participant enrolled
November 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 28, 2033
April 21, 2026
April 1, 2026
4.2 years
September 25, 2025
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of participants with dose limiting toxicities (DLTs) in dose escalation in Part 1 and Part 2 participants only
Any AE occurring during the DLT observation period that is attributed to PF-08052667 and not to the underlying disease or other causes is considered a DLT. DLT rate estimated based on data from DLT-evaluable participants during the DLT evaluation period.
Day of first dose (Day 1) Up to 21 days
Number of participants with adverse events (AEs) in Part 1 and Part 2 participants only
AEs as characterized by type, frequency, severity (CTCAE v5.0), seriousness, and relatedness to study drug(s).
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with laboratory abnormalities in Part 1 and Part 2 participants only
Laboratory abnormalities as characterized by type, frequency, severity
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Recurrence-free survival (RFS) in Part 3 participants only
RFS is defined as the time from the first dose until recurrence of high-grade disease, or death due to any cause, whichever occurs first
Through end of study and up to approximately 2 years
Event-free survival (EFS) in Part 3 participants only
EFS is defined as the time from the first dose until the first occurrence of an EFS event including progressive disease, recurrence of high-grade disease, or death due to any cause, whichever occurs first
Through end of study and up to approximately 2 years
Secondary Outcomes (15)
PK: Maximum Observed Serum Concentration (Cmax)
From the first day through 30-37 days after the last study treatment
PK: Time to Reach Maximum Observed Serum Concentration (Tmax)
From the first day through 30-37 days after the last study treatment
PK: Minimum observed serum concentration (Ctrough)
From the first day through 30-37 days after the last study treatment
PK: Area under the concentration-time curve (AUC) from time zero to last (AUC from time 0 to AUClast)
From the first day through 30-37 days after the last study treatment
PK: Half-life (t1/2)
From the first day through 30-37 days after the last study treatment
- +10 more secondary outcomes
Study Arms (3)
Monotherapy Dose Escalation
EXPERIMENTALPF-08052667 will be administered through intravesical instillation at defined dose levels. Dosing schedule is on Day 1, 8 and 15 of a 21-day cycle.
Combination Therapy Dose Escalation
EXPERIMENTALPF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1
Dose Optimization and Expansion
EXPERIMENTALPF-08052667 monotherapy or in combination with BCG and/or sasanlimab at dose levels/schedules for PF-08052667 determined in Parts 1 and 2.
Interventions
PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash
Sasanlimab will be administered as subcutaneous (SC) injection
BCG will be administered intravesical (IVe) instillation
PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (47)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Moffitt Cancer Center at SouthShore
Ruskin, Florida, 33570, United States
Moffitt Cancer Center - International Plaza
Tampa, Florida, 33607, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Moffitt McKinley Hospital
Tampa, Florida, 33612, United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, 60611, United States
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
The University of Kansas - Clinical Research Center
Fairway, Kansas, 66205, United States
The University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, 66160, United States
The University of Kansas Hospital
Kansas City, Kansas, 66160, United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, 66160, United States
The University of Kansas Hospital - Indian Creek Campus
Overland Park, Kansas, 66211, United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Upstate Specialty Services at Harrison Center
Syracuse, New York, 13202, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
SUNY Upstate Medical University-Community Campus
Syracuse, New York, 13215, United States
Biorepository and Precision Pathology Center (BRPC)
Durham, North Carolina, 27710, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Substrate Services Core Research Support (SSCRS)
Durham, North Carolina, 27710, United States
Grand Strand Medical Center
Myrtle Beach, South Carolina, 295724607, United States
AUC Urologists, LLC
Myrtle Beach, South Carolina, 29572, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, 29572, United States
Coastal Eye Group
Myrtle Beach, South Carolina, 29579, United States
Urology Associates, P.C.
Nashville, Tennessee, 37209, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Baptist M&S Imaging (Medical Center)
San Antonio, Texas, 78229, United States
USA Clinical Trials
San Antonio, Texas, 78229, United States
MCOA Eye Associates
San Antonio, Texas, 78240, United States
Gustave Roussy
Villejuif, VAL DE Marne, 94800, France
Rabin Medical Center
Petah Tikva, Central District, 4941492, Israel
Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Samsung Medical Center
Seoul, Seoul Teukbyeolsi [seoul], 06351, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi, 03722, South Korea
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Publications (1)
Carosino CM, Olson DJ, Mazahreh RC, Ortiz DJ, Duniho S, Moskovitz E, Gray M, Hein RF, Garcia NH, Ardalani H, Farr L, Yan T, Burcher M, Mikell I, Levengood MR, Sandall S, Dekker JD. An Integrin beta6-targeted antibody-drug conjugate optimized for intravesical delivery to treat non-muscle invasive bladder cancer. Mol Cancer Ther. 2026 Apr 20. doi: 10.1158/1535-7163.MCT-26-0077. Online ahead of print.
PMID: 42008114DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2025
First Posted
October 3, 2025
Study Start
November 6, 2025
Primary Completion (Estimated)
January 29, 2030
Study Completion (Estimated)
January 28, 2033
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.