A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer

RECRUITING

NCT07206225

PHASE1

Sponsor: Pfizer

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

294

Start Date

2025-11-06

Completion Date

2033-01-28

Last Updated

2026-04-07

Healthy Volunteers

No

Conditions

Non-muscle Invasive Bladder Cancer

Interventions

DRUG

PF-08052667

PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash

DRUG

Sasanlimab

Sasanlimab will be administered as subcutaneous (SC) injection

DRUG

BCG

BCG will be administered intravesical (IVe) instillation

DRUG

PF-02921367

PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation

Locations (42)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

AdventHealth Orlando

Orlando, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, United States

University of Iowa Health Care

Iowa City, Iowa, United States

The University of Kansas - Clinical Research Center

Fairway, Kansas, United States

The University of Kansas Hospital Cambridge North Tower A

Kansas City, Kansas, United States

The University of Kansas Hospital

Kansas City, Kansas, United States

The University of Kansas Medical Center Medical Office Building

Kansas City, Kansas, United States

The University of Kansas Hospital - Indian Creek Campus

Overland Park, Kansas, United States

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, United States

Icahn School of Medicine at Mount Sinai

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

Biorepository and Precision Pathology Center (BRPC)

Durham, North Carolina, United States

Duke Cancer Institute

Durham, North Carolina, United States

Substrate Services Core Research Support (SSCRS)

Durham, North Carolina, United States

Grand Strand Medical Center