Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07206225

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

Led by Pfizer · Updated on 2026-04-21

294

Participants Needed

47

Research Sites

377 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 as carcinoma in situ (CIS), with or without T1/Ta papillary disease
  • For BCG unresponsive and BCG-exposed cohorts, persistent or recurrent disease after receiving at least 5 of 6 doses of BCG induction therapy
  • Have refused or are ineligible or not appropriate for radical cystectomy
  • Available tumor tissue sample within the last 6 months
  • ECOG Performance Status of 0 or 1
Not Eligible

You will not qualify if you...

  • Receiving other anti-cancer therapy for non-muscle invasive bladder cancer or prior radiation therapy to the bladder
  • Having renal or hepatic impairment or certain blood abnormalities as defined in the protocol
  • Having an active, uncontrolled infection as specified in the protocol

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 47 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Not Yet Recruiting

2

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249

Not Yet Recruiting

3

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Not Yet Recruiting

4

AdventHealth Orlando

Orlando, Florida, United States, 32803

Not Yet Recruiting

5

Moffitt Cancer Center at SouthShore

Ruskin, Florida, United States, 33570

Not Yet Recruiting

6

Moffitt Cancer Center - International Plaza

Tampa, Florida, United States, 33607

Not Yet Recruiting

7

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States, 33612

Not Yet Recruiting

8

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Not Yet Recruiting

9

Moffitt McKinley Hospital

Tampa, Florida, United States, 33612

Not Yet Recruiting

10

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States, 33544

Not Yet Recruiting

11

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Actively Recruiting

12

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

13

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

14

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Not Yet Recruiting

15

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Not Yet Recruiting

16

University of Iowa Health Care

Iowa City, Iowa, United States, 52242

Not Yet Recruiting

17

The University of Kansas - Clinical Research Center

Fairway, Kansas, United States, 66205

Actively Recruiting

18

The University of Kansas Hospital Cambridge North Tower A

Kansas City, Kansas, United States, 66160

Actively Recruiting

19

The University of Kansas Hospital

Kansas City, Kansas, United States, 66160

Actively Recruiting

20

The University of Kansas Medical Center Medical Office Building

Kansas City, Kansas, United States, 66160

Actively Recruiting

21

The University of Kansas Hospital - Indian Creek Campus

Overland Park, Kansas, United States, 66211

Actively Recruiting

22

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, United States, 66205

Actively Recruiting

23

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Not Yet Recruiting

24

Upstate Specialty Services at Harrison Center

Syracuse, New York, United States, 13202

Not Yet Recruiting

25

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

Not Yet Recruiting

26

SUNY Upstate Medical University-Community Campus

Syracuse, New York, United States, 13215

Not Yet Recruiting

27

Biorepository and Precision Pathology Center (BRPC)

Durham, North Carolina, United States, 27710

Actively Recruiting

28

Duke Cancer Institute

Durham, North Carolina, United States, 27710

Actively Recruiting

29

Substrate Services Core Research Support (SSCRS)

Durham, North Carolina, United States, 27710

Actively Recruiting

30

Grand Strand Medical Center

Myrtle Beach, South Carolina, United States, 295724607

Actively Recruiting

31

AUC Urologists, LLC

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

32

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

33

Parkway Surgery Center

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

34

Coastal Eye Group

Myrtle Beach, South Carolina, United States, 29579

Actively Recruiting

35

Urology Associates, P.C.

Nashville, Tennessee, United States, 37209

Actively Recruiting

36

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Not Yet Recruiting

37

Baptist M&S Imaging (Medical Center)

San Antonio, Texas, United States, 78229

Actively Recruiting

38

USA Clinical Trials

San Antonio, Texas, United States, 78229

Actively Recruiting

39

MCOA Eye Associates

San Antonio, Texas, United States, 78240

Actively Recruiting

40

Gustave Roussy

Villejuif, VAL DE Marne, France, 94800

Not Yet Recruiting

41

Rabin Medical Center

Petah Tikva, Central District, Israel, 4941492

Actively Recruiting

42

Sheba Medical Center

Ramat Gan, Central District, Israel, 5265601

Actively Recruiting

43

Hadassah Medical Center

Jerusalem, Jerusalem, Israel, 9112001

Actively Recruiting

44

Samsung Medical Center

Seoul, Seoul Teukbyeolsi [seoul], South Korea, 06351

Not Yet Recruiting

45

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080

Not Yet Recruiting

46

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi, South Korea, 03722

Not Yet Recruiting

47

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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