NCT07206225RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 294 (estimated)
- First submitted
- 25 Sept 2025
- Start date
- 6 Nov 2025
- Primary completion date
- 29 Jan 2030
- Lead sponsor
- Pfizer
- Diseases
- Bladder cancer
- NCT number
- NCT07206225
- EU CT number
- 2025-521756-39-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 294
- From 6 Nov 2025 to the primary completion date, 29 Jan 2030
- 71 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed
Other illness
- Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol
- Participants with active, uncontrolled infection as specified in the protocol
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (71)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundació Puigvert Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Weston Park Cancer Centre Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Sheffield Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| The University of Sheffield Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Not yet recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Children's Center Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| MSK Basking Ridge. Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| UAB Infusion Therapy Extended Care Clinic (ECC) Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| The University of Alabama at Birmingham Investigation Drug Services Pharmacy Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| The Kirklin Clinic of UAB Hospital Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Northwestern University Feinberg School of Medicine Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| MSK Commack. Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| The University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| UT Southwestern Medical Center-William P. Clements Imaging Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Cancer Center Outpatient Building Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| UT Southwestern Medical Center - West Campus Building Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| UT Southwestern Medical Center - William P Clements Jr University Hospital Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Substrate Services Core Research Support (SSCRS) Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Biorepository and Precision Pathology Center (BRPC) Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| The University of Kansas - Clinical Research Center Coordinator of this site? Confirm its status | Fairway | United States | Recruiting |
| MSK Westchester. Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| University of Iowa Health Care Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| The University of Kansas Hospital Cambridge North Tower A Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| The University of Kansas Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| The University of Kansas Medical Center Medical Office Building Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| MSK Monmouth. Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| MSK Bergen. Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Parkway Surgery Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| Coastal Eye Group Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| AUC Urologists, LLC Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| Carolina Urologic Research Center, LLC Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| Grand Strand Medical Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| Urology Associates, P.C. Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| 64th Street Outpatient and Innovation Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center 53rd street. Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - Main Campus Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| The University of Kansas Hospital - Indian Creek Campus Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Moffitt Cancer Center at SouthShore Coordinator of this site? Confirm its status | Ruskin | United States | Recruiting |
| MCOA Eye Associates Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Baptist M&S Imaging (Medical Center) Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| USA Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| SUNY Upstate Medical University-Community Campus Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Upstate Specialty Services at Harrison Center Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Moffitt Cancer Center - McKinley Campus Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt Cancer Center-International Plaza Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt McKinley Hospital Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| MSK Nassau. Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
| Moffitt Cancer Center at Wesley Chapel Coordinator of this site? Confirm its status | Wesley Chapel | United States | Recruiting |
| The University of Kansas Cancer Center - Westwood Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
Related publications
- An Integrin β6-Targeted Antibody-Drug Conjugate Optimized for Intravesical Delivery to Treat Non-Muscle-Invasive Bladder Cancer.Mol Cancer Ther · 2026 · PMID 42008114
This page is information, not medical advice. Discuss any trial with your doctor.