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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Sasanlimab: Sasanlimab will be administered as subcutaneous (SC) injection

BCG: BCG will be administered intravesical (IVe) instillation

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

Study 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.

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.

Eligibility

Primary outcome measure(s)

• Number of participants with dose limiting toxicities (DLTs) in dose escalation in Part 1 and Part 2 participants only — Day of first dose (Day 1) Up to 21 days
  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.
• Number of participants with adverse events (AEs) in Part 1 and Part 2 participants only — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
  AEs as characterized by type, frequency, severity (CTCAE v5.0), seriousness, and relatedness to study drug(s).
• Number of participants with laboratory abnormalities in Part 1 and Part 2 participants only — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
  Laboratory abnormalities as characterized by type, frequency, severity
• Recurrence-free survival (RFS) in Part 3 participants only — Through end of study and up to approximately 2 years
  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
• Event-free survival (EFS) in Part 3 participants only — Through end of study and up to approximately 2 years
  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

Trial sites (68)

+ 28 more sites — see the full list on the official registry below.

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