Recruiting

Phase 1

PF-08052667 & BCG & SasanlimabA Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer

Sponsor:

Pfizer

Code:

NCT07206225

Conditions

Non-muscle Invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08052667

Sasanlimab

BCG

PF-02921367

Study Details

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.

Conditions

Non-muscle Invasive Bladder Cancer

Study ID

NCT07206225

Start date

Nov 6, 2025

Status verified date

Aug, 2026

Completion date

Jan 28, 2033

Anticipated

Primary completion date

Jan 29, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

1. 18 years of age or older (or the minimum age of consent per local regulations)
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:

1. Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed
2. Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol
3. Participants with active, uncontrolled infection as specified in the protocol

Study Design

Enrollment

294 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: Combination Therapy Dose Escalation

PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1

experimental: 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.

Interventions

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

Primary outcome measure

Number of participants with dose limiting toxicities (DLTs) in dose escalation in Part 1 and Part 2 participants only [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through end of study and up to approximately 2 years ]
Event-free survival (EFS) in Part 3 participants only [ Time Frame: Through end of study and up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

The Kirklin Clinic of UAB Hospital

Recruiting

Birmingham, Alabama, United States, 35233

UAB Infusion Therapy Extended Care Clinic (ECC)

Recruiting

Birmingham, Alabama, United States, 35233

The University of Alabama at Birmingham Investigation Drug Services Pharmacy

Recruiting

Birmingham, Alabama, United States, 35249

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Moffitt Cancer Center at SouthShore

Recruiting

Ruskin, Florida, United States, 33570

Moffitt Cancer Center - International Plaza

Recruiting

Tampa, Florida, United States, 33607

Moffitt Cancer Center - McKinley Campus

Recruiting

Tampa, Florida, United States, 33612

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Moffitt McKinley Hospital

Recruiting

Tampa, Florida, United States, 33612

Moffitt Cancer Center at Wesley Chapel

Recruiting

Wesley Chapel, Florida, United States, 33544

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

The University of Kansas - Clinical Research Center

Recruiting

Fairway, Kansas, United States, 66205

The University of Kansas Hospital Cambridge North Tower A

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Medical Center Medical Office Building

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Hospital - Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

The University of Kansas Cancer Center - Westwood

Recruiting

Westwood, Kansas, United States, 66205

MSK Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

MSK Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

MSK Bergen

Recruiting

Montvale, New Jersey, United States, 07645

MSK Commack

Recruiting

Commack, New York, United States, 11725

MSK Westchester

Recruiting

Harrison, New York, United States, 10604

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

Recruiting

New York, New York, United States, 10021

Memorial Sloan Kettering Cancer Center 53rd street

Recruiting

New York, New York, United States, 10022

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

64th Street Outpatient and Innovation Center

Recruiting

New York, New York, United States, 10065

Memorial Sloan Kettering Cancer Center - Main Campus

Recruiting

New York, New York, United States, 10065

Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Upstate Specialty Services at Harrison Center

Recruiting

Syracuse, New York, United States, 13202

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

SUNY Upstate Medical University-Community Campus

Recruiting

Syracuse, New York, United States, 13215

MSK Nassau

Recruiting

Uniondale, New York, United States, 11553

Biorepository and Precision Pathology Center (BRPC)

Recruiting

Durham, North Carolina, United States, 27710

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Substrate Services Core Research Support (SSCRS)

Recruiting

Durham, North Carolina, United States, 27710

Grand Strand Medical Center

Recruiting

Myrtle Beach, South Carolina, United States, 295724607

AUC Urologists, LLC

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Carolina Urologic Research Center, LLC

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Parkway Surgery Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Coastal Eye Group

Recruiting

Myrtle Beach, South Carolina, United States, 29579

Urology Associates, P.C.

Recruiting

Nashville, Tennessee, United States, 37209

Cancer Center Outpatient Building

Recruiting

Dallas, Texas, United States, 75235

The University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

UT Southwestern Medical Center - West Campus Building

Recruiting

Dallas, Texas, United States, 75390

UT Southwestern Medical Center - William P Clements Jr University Hospital

Recruiting

Dallas, Texas, United States, 75390

UT Southwestern Medical Center-William P. Clements Imaging Center

Recruiting

Dallas, Texas, United States, 75390

Baptist M&S Imaging (Medical Center)

Recruiting

San Antonio, Texas, United States, 78229

USA Clinical Trials

Recruiting

San Antonio, Texas, United States, 78229

MCOA Eye Associates

Recruiting

San Antonio, Texas, United States, 78240

More Information

Sponsor

Pfizer

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

NMIBC
Non-Muscle Invasive Bladder Cancer
Bladder Cancer
Bladder Tumors
Bladder Neoplasms
Malignant Tumor of Urinary Bladder
Urinary Bladder Cancer
Cancer of Bladder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-17.