A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
NCT ID: NCT07206225
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
294 participants
INTERVENTIONAL
2025-11-06
2033-01-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy Dose Escalation
PF-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.
PF-08052667
PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash
PF-02921367
PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation
Combination Therapy Dose Escalation
PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1
PF-08052667
PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash
Sasanlimab
Sasanlimab will be administered as subcutaneous (SC) injection
BCG
BCG will be administered intravesical (IVe) instillation
PF-02921367
PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation
Dose Optimization and Expansion
PF-08052667 monotherapy or in combination with BCG and/or sasanlimab at dose levels/schedules for PF-08052667 determined in Parts 1 and 2.
PF-08052667
PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash
Sasanlimab
Sasanlimab will be administered as subcutaneous (SC) injection
BCG
BCG will be administered intravesical (IVe) instillation
PF-02921367
PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation
Interventions
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PF-08052667
PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash
Sasanlimab
Sasanlimab will be administered as subcutaneous (SC) injection
BCG
BCG will be administered intravesical (IVe) instillation
PF-02921367
PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol
3. Participants with active, uncontrolled infection as specified in the protocol
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
UCLA Hematology/Oncology - Westwood (Building 300)
Los Angeles, California, United States
AdventHealth Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Evanston, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
The University of Kansas - Clinical Research Center
Fairway, Kansas, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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
Duke Cancer Institute
Durham, North Carolina, United States
AUC Urologists, LLC
Myrtle Beach, South Carolina, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
Grand Strand Medical Center
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
UT Southwestern Medical Center-William P. Clements Imaging Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, 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
Pitie Salpetriere University Hospital
Paris, Other, France
Gustave Roussy
Villejuif, Other, France
Rambam Health Care Campus
Haifa, Other, Israel
Hadassah Medical Center
Jerusalem, Other, Israel
Rabin Medical Center
Petah Tikva, Other, Israel
Sheba Medical Center
Ramat Gan, Other, Israel
Severance Hospital, Yonsei University Health System
Seoul, Other, South Korea
Samsung Medical Center
Seoul, Other, South Korea
Fundació Puigvert
Barcelona, Other, Spain
Hospital Universitario 12 de Octubre
Madrid, Other, Spain
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, Other, United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C6001001
Identifier Type: -
Identifier Source: org_study_id