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Non-muscle Invasive Bladder CancerPhase 1NCT07206225

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

A Phase 1 study testing PF-08052667, Sasanlimab and BCG in people with Non-muscle Invasive Bladder Cancer, run by Pfizer at 68 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-muscle Invasive Bladder Cancer
What is being tested?
PF-08052667, Sasanlimab and BCG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
294 participants
Where
68 sitesin 6 countries
Study dates
6 Nov 2025to 28 Jan 2033
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

68 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

68 sites in 6 countries

United States54 sites, 54 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

    Recruiting

  • The Kirklin Clinic of UAB Hospital

    Birmingham, Alabama, 35233

    Recruiting

  • UAB Infusion Therapy Extended Care Clinic (ECC)

    Birmingham, Alabama, 35233

    Recruiting

  • The University of Alabama at Birmingham Investigation Drug Services Pharmacy

    Birmingham, Alabama, 35249

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Not yet recruiting

  • Northwestern University - Feinberg School of Medicine

    Chicago, Illinois, 60611

    Not yet recruiting

  • MSK Commack

    Commack, New York, 11725

    Recruiting

  • Cancer Center Outpatient Building

    Dallas, Texas, 75235

    Recruiting

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • UT Southwestern Medical Center - West Campus Building

    Dallas, Texas, 75390

    Recruiting

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

    Dallas, Texas, 75390

    Recruiting

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

    Dallas, Texas, 75390

    Recruiting

  • Biorepository and Precision Pathology Center (BRPC)

    Durham, North Carolina, 27710

    Recruiting

  • Duke Cancer Institute

    Durham, North Carolina, 27710

    Recruiting

  • Substrate Services Core Research Support (SSCRS)

    Durham, North Carolina, 27710

    Recruiting

  • The University of Kansas - Clinical Research Center

    Fairway, Kansas, 66205

    Recruiting

  • MSK Westchester

    Harrison, New York, 10604

    Recruiting

  • University of Iowa Health Care

    Iowa City, Iowa, 52242

    Recruiting

  • The University of Kansas Hospital Cambridge North Tower A

    Kansas City, Kansas, 66160

    Recruiting

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160

    Recruiting

  • The University of Kansas Medical Center Medical Office Building

    Kansas City, Kansas, 66160

    Recruiting

  • MSK Monmouth

    Middletown, New Jersey, 07748

    Recruiting

  • MSK Bergen

    Montvale, New Jersey, 07645

    Recruiting

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina, 295724607

    Recruiting

  • AUC Urologists, LLC

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Parkway Surgery Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Coastal Eye Group

    Myrtle Beach, South Carolina, 29579

    Recruiting

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

    Recruiting

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

    New York, New York, 10021

    Recruiting

  • Memorial Sloan Kettering Cancer Center 53rd street

    New York, New York, 10022

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • 64th Street Outpatient and Innovation Center

    New York, New York, 10065

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065

    Recruiting

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

    New York, New York, 10065

    Recruiting

  • The University of Kansas Hospital - Indian Creek Campus

    Overland Park, Kansas, 66211

    Recruiting

  • Moffitt Cancer Center at SouthShore

    Ruskin, Florida, 33570

    Recruiting

  • Baptist M&S Imaging (Medical Center)

    San Antonio, Texas, 78229

    Recruiting

  • USA Clinical Trials

    San Antonio, Texas, 78229

    Recruiting

  • MCOA Eye Associates

    San Antonio, Texas, 78240

    Recruiting

  • Upstate Specialty Services at Harrison Center

    Syracuse, New York, 13202

    Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

    Recruiting

  • SUNY Upstate Medical University-Community Campus

    Syracuse, New York, 13215

    Recruiting

  • Moffitt Cancer Center - International Plaza

    Tampa, Florida, 33607

    Recruiting

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • Moffitt McKinley Hospital

    Tampa, Florida, 33612

    Recruiting

  • MSK Nassau

    Uniondale, New York, 11553

    Recruiting

  • Moffitt Cancer Center at Wesley Chapel

    Wesley Chapel, Florida, 33544

    Recruiting

  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205

    Recruiting

Other trials in United States

Israel4 sites, 4 recruiting

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601

    Not yet recruiting

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

    Recruiting

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492

    Recruiting

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

    Recruiting

Other trials in Israel

United Kingdom4 sites, 4 recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, England, S10 2SJ

    Recruiting

  • Royal Hallamshire Hospital

    Sheffield, South Yorkshire, S10 2JF

    Recruiting

  • The University of Sheffield

    Sheffield, S10 2RX

    Recruiting

  • Weston Park Cancer Centre

    Sheffield, S10 2SJ

    Recruiting

Other trials in United Kingdom

South Korea3 sites, 3 recruiting

  • Samsung Medical Center

    Seoul, Seoul Teukbyeolsi [seoul], 06351

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi, 03722

    Recruiting

Other trials in South Korea

France2 sites, 2 recruiting

  • Pitie Salpetriere University Hospital

    Paris, 75013

    Recruiting

  • Gustave Roussy

    Villejuif, VAL DE Marne, 94800

    Recruiting

Other trials in France

Spain1 site, 1 recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

Other trials in Spain

About this study

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

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.

Read more

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.

Being tested
PF-08052667, Sasanlimab, BCG, PF-02921367
Keywords
NMIBC, Non-Muscle Invasive Bladder Cancer, Bladder Cancer, Bladder Tumors, Bladder Neoplasms, Malignant Tumor of Urinary Bladder, Urinary Bladder Cancer, Cancer of Bladder
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08052667Drug

    Also called SGN-B6N

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

  • SasanlimabDrug

    Also called PF-06801591

    Sasanlimab will be administered as subcutaneous (SC) injection

  • BCGDrug

    BCG will be administered intravesical (IVe) instillation

  • PF-02921367Drug

    Also called DDM

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

Study groups in NCT07206225
Study groupRoleWhat they receive
Monotherapy Dose EscalationExperimentalPF-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.
Receives: Drug: PF-08052667; Drug: PF-02921367
Combination Therapy Dose EscalationExperimentalPF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1
Receives: Drug: PF-08052667; Drug: Sasanlimab; Drug: BCG; Drug: PF-02921367
Dose Optimization and ExpansionExperimentalPF-08052667 monotherapy or in combination with BCG and/or sasanlimab at dose levels/schedules for PF-08052667 determined in Parts 1 and 2.
Receives: Drug: PF-08052667; Drug: Sasanlimab; Drug: BCG; Drug: PF-02921367

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with dose limiting toxicities (DLTs) in dose escalation in Part 1 and Part 2 participants only

    Any AE occurring during the DLT observation period that is attributed to PF-08052667 and not to the underlying disease or other causes is considered a DLT. DLT rate estimated based on data from DLT-evaluable participants during the DLT evaluation period.

    Measured: Day of first dose (Day 1) Up to 21 days

  2. Number of participants with adverse events (AEs) in Part 1 and Part 2 participants only

    AEs as characterized by type, frequency, severity (CTCAE v5.0), seriousness, and relatedness to study drug(s).

    Measured: From the first day through 30-37 days after the last study treatment, up to approximately 2 years

  3. Number of participants with laboratory abnormalities in Part 1 and Part 2 participants only

    Laboratory abnormalities as characterized by type, frequency, severity

    Measured: From the first day through 30-37 days after the last study treatment, up to approximately 2 years

  4. Recurrence-free survival (RFS) in Part 3 participants only

    RFS is defined as the time from the first dose until recurrence of high-grade disease, or death due to any cause, whichever occurs first

    Measured: Through end of study and up to approximately 2 years

  5. Event-free survival (EFS) in Part 3 participants only

    EFS is defined as the time from the first dose until the first occurrence of an EFS event including progressive disease, recurrence of high-grade disease, or death due to any cause, whichever occurs first

    Measured: Through end of study and up to approximately 2 years

Secondary outcomes (15)

  1. PK: Maximum Observed Serum Concentration (Cmax)

    Cmax of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)

    Measured: From the first day through 30-37 days after the last study treatment

  2. PK: Time to Reach Maximum Observed Serum Concentration (Tmax)

    Tmax of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)

    Measured: From the first day through 30-37 days after the last study treatment

  3. PK: Minimum observed serum concentration (Ctrough)

    Ctrough of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)

    Measured: From the first day through 30-37 days after the last study treatment

  4. PK: Area under the concentration-time curve (AUC) from time zero to last (AUC from time 0 to AUClast)

    AUClast of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)

    Measured: From the first day through 30-37 days after the last study treatment

  5. PK: Half-life (t1/2)

    Measured: From the first day through 30-37 days after the last study treatment

  6. Incidence of Anti-Drug Antibody (ADA): Immunogenicity of PF-08052667 as a single agent (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)

    Incidence and titers of ADA and neutralizing antibody against PF-08052667

    Measured: Through 30-37 days after the last study treatment, up to approximately 2 years

  7. Duration of Complete Response (CR) in Part 1 and Part 2 participants only

    Duration of CR is the time from first documentation of CR until the first occurrence of an Event-free survival (EFS) event

    Measured: Through end of study and up to approximately 2 years

  8. Complete Response Rate (CRR) in Part 1 and Part 2 participants only

    CR rate is defined as the proportion of subjects achieving CR

    Measured: Through end of study and up to approximately 2 years

  9. Overall survival (OS) in Part 3 participants only

    Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause

    Measured: Through end of study approximately 5 years from last participant enrollment

  10. Cystectomy-free survival in all Parts

    Cystectomy-free survival is defined as the time from the first dose until cystectomy or death due to any cause, whichever occurs first

    Measured: Through end of study and up to approximately 2 years

  11. Event-free survival (EFS) in Part 1 and Part 2 participants only

    EFS is defined as the time from the first dose until the first occurrence of an EFS event including progressive disease, recurrence of high-grade disease, or death due to any cause, whichever occurs first

    Measured: Through end of study and up to approximately 2 years

  12. Recurrence-free survival (RFS) in Part 1 and Part 2 participants only

    RFS is defined as the time from the first dose until recurrence of high-grade disease, or death due to any cause, whichever occurs first

    Measured: Through end of study and up to approximately 2 years

  13. Rate of cystectomy in all parts

    Rate of cystectomy is defined as the proportion of participants who had a cystectomy while on study

    Measured: Through end of study and up to approximately 2 years

  14. Number of participants with adverse events (AEs) in Part 3 participants only

    AEs as characterized by type, frequency, severity (CTCAE v5.0), seriousness, and relatedness to study drug(s)

    Measured: From the first day through 30-37 days after the last study treatment, up to approximately 2 years

  15. Number of participants with laboratory abnormalities in Part3 participants only

    Laboratory abnormalities as characterized by type, frequency, severity

    Measured: From the first day through 30-37 days after the last study treatment, up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start6 Nov 2025
  3. Primary completion29 Jan 2030 (estimated)
  4. Study completion28 Jan 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
294 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07206225
Sponsor's protocol ID
C6001001
Status last verified
Oct 2026
First submitted
25 Sep 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Carosino CM, Olson DJ, Mazahreh RC, Ortiz DJ, Duniho S, Moskovitz E, Gray M, Hein RF, Garcia NH, Ardalani H, Farr L, Yan T, Burcher M, Mikell I, Levengood MR, Sandall S, Dekker JD. An Integrin beta6-targeted antibody-drug conjugate optimized for intravesical delivery to treat non-muscle invasive bladder cancer. Mol Cancer Ther. 2026 Apr 20. doi: 10.1158/1535-7163.MCT-26-0077. Online ahead of print.

    PubMed 42008114

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-08052667, Sasanlimab and BCG in people with Non-muscle Invasive Bladder Cancer, run by Pfizer at 68 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Israel, United Kingdom, South Korea, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07206225, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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