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New bladder cancer drug shows promise in early trial

NCT ID NCT07206225

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This study tests a new drug called PF-08052667 for adults with a type of bladder cancer that hasn't spread into the muscle layer but is likely to return. The drug is given directly into the bladder, sometimes with other medicines like BCG or sasanlimab. The trial has three parts to find the best dose and see how safe and effective the drug is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PF-08052667 (a drug given directly into the bladder)
What this could lead to
If it works, this could offer a new treatment option for people with bladder cancer that hasn't responded to standard therapies.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it's too soon to know if the drug will be effective. Side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 294 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ bladder papillary urothelial carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non muscle invasive bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    68 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 64th Street Outpatient and Innovation Center

    RECRUITING

    New York, New York, 10065, United States

  • AUC Urologists, LLC

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Baptist M&S Imaging (Medical Center)

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Biorepository and Precision Pathology Center (BRPC)

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Cancer Center Outpatient Building

    RECRUITING

    Dallas, Texas, 75235, United States

  • Carolina Urologic Research Center, LLC

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Coastal Eye Group

    RECRUITING

    Myrtle Beach, South Carolina, 29579, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Grand Strand Medical Center

    RECRUITING

    Myrtle Beach, South Carolina, 295724607, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, VAL DE Marne, 94800, France

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, Jerusalem, 9112001, Israel

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • MCOA Eye Associates

    RECRUITING

    San Antonio, Texas, 78240, United States

  • MSK Basking Ridge

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • MSK Bergen

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • MSK Commack

    RECRUITING

    Commack, New York, 11725, United States

  • MSK Monmouth

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • MSK Nassau

    RECRUITING

    Uniondale, New York, 11553, United States

  • MSK Westchester

    RECRUITING

    Harrison, New York, 10604, United States

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

    RECRUITING

    New York, New York, 10021, United States

  • Memorial Sloan Kettering Cancer Center - Main Campus

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center 53rd street

    RECRUITING

    New York, New York, 10022, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Moffitt Cancer Center - International Plaza

    RECRUITING

    Tampa, Florida, 33607, United States

  • Moffitt Cancer Center - McKinley Campus

    RECRUITING

    Tampa, Florida, 33612, United States

  • Moffitt Cancer Center at SouthShore

    RECRUITING

    Ruskin, Florida, 33570, United States

  • Moffitt Cancer Center at Wesley Chapel

    RECRUITING

    Wesley Chapel, Florida, 33544, United States

  • Moffitt McKinley Hospital

    RECRUITING

    Tampa, Florida, 33612, United States

  • Northwestern Memorial Hospital

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Northwestern University - Feinberg School of Medicine

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Parkway Surgery Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Pitie Salpetriere University Hospital

    RECRUITING

    Paris, 75013, France

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus

    NOT_YET_RECRUITING

    Haifa, Northern District, 3109601, Israel

  • Royal Hallamshire Hospital

    RECRUITING

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • SUNY Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • SUNY Upstate Medical University-Community Campus

    RECRUITING

    Syracuse, New York, 13215, United States

  • Samsung Medical Center

    RECRUITING

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

  • Seoul National University Hospital

    RECRUITING

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

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5265601, Israel

  • Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, England, S10 2SJ, United Kingdom

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

    RECRUITING

    New York, New York, 10065, United States

  • Substrate Services Core Research Support (SSCRS)

    RECRUITING

    Durham, North Carolina, 27710, United States

  • The Kirklin Clinic of UAB Hospital

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • The University of Alabama at Birmingham Investigation Drug Services Pharmacy

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • The University of Kansas - Clinical Research Center

    RECRUITING

    Fairway, Kansas, 66205, United States

  • The University of Kansas Cancer Center - Westwood

    RECRUITING

    Westwood, Kansas, 66205, United States

  • The University of Kansas Hospital

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • The University of Kansas Hospital - Indian Creek Campus

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • The University of Kansas Hospital Cambridge North Tower A

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • The University of Kansas Medical Center Medical Office Building

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • The University of Sheffield

    RECRUITING

    Sheffield, S10 2RX, United Kingdom

  • The University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • UAB Infusion Therapy Extended Care Clinic (ECC)

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • USA Clinical Trials

    RECRUITING

    San Antonio, Texas, 78229, United States

  • UT Southwestern Medical Center - West Campus Building

    RECRUITING

    Dallas, Texas, 75390, United States

  • UT Southwestern Medical Center - William P Clements Jr University Hospital

    RECRUITING

    Dallas, Texas, 75390, United States

  • UT Southwestern Medical Center-William P. Clements Imaging Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Upstate Specialty Services at Harrison Center

    RECRUITING

    Syracuse, New York, 13202, United States

  • Urology Associates, P.C.

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Weston Park Cancer Centre

    RECRUITING

    Sheffield, S10 2SJ, United Kingdom

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