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OncoMatch/Clinical Trials/NCT07206225

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

Is NCT07206225 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including PF-08052667 and Sasanlimab for non-muscle invasive bladder cancer.

Phase 1RecruitingPfizerNCT07206225Data as of May 2026

Treatment: PF-08052667 · Sasanlimab · BCG · PF-02921367The 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.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Disease stage

Required: Stage CIS

Grade: high-riskhigh-grade (who)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: BCG therapy

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

Cannot have received: radiation therapy to the bladder

prior radiation therapy to the bladder are not allowed

Lab requirements

Blood counts

no hematologic abnormalities as defined in the protocol

Kidney function

no renal impairment as defined in the protocol

Liver function

no hepatic impairment as defined in the protocol

Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama at Birmingham · Birmingham, Alabama
  • UCLA Hematology/Oncology - Westwood (Building 300) · Los Angeles, California
  • AdventHealth Orlando · Orlando, Florida
  • Moffitt Cancer Center at SouthShore · Ruskin, Florida
  • Moffitt Cancer Center - International Plaza · Tampa, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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