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

Conditions

• Non-muscle Invasive Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-08052667 — DRUG
  PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash
• Sasanlimab — DRUG
  Sasanlimab will be administered as subcutaneous (SC) injection
• BCG — DRUG
  BCG will be administered intravesical (IVe) instillation
• PF-02921367 — DRUG
  PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation

Study Details

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.

Key Dates

Start date

Nov 6, 2025

Status verified

Apr 2026

Primary completion

Jan 29, 2030

Completion

Jan 28, 2033

Study Design

Enrollment

294 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Monotherapy Dose Escalation
  PF-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.
• Experimental: Combination Therapy Dose Escalation
  PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1
• Experimental: Dose Optimization and Expansion
  PF-08052667 monotherapy or in combination with BCG and/or sasanlimab at dose levels/schedules for PF-08052667 determined in Parts 1 and 2.

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 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (39)

Find similar trials in Birmingham, AL

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