A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
- Conditions
- Non-muscle Invasive Bladder Cancer
- Interventions
- Registration Number
- NCT07206225
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 294
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy Dose Escalation PF-08052667 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. Monotherapy Dose Escalation PF-02921367 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. Combination Therapy Dose Escalation PF-08052667 PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1 Combination Therapy Dose Escalation Sasanlimab PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1 Combination Therapy Dose Escalation BCG PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1 Combination Therapy Dose Escalation PF-02921367 PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1 Dose Optimization and Expansion PF-08052667 PF-08052667 monotherapy or in combination with BCG and/or sasanlimab at dose levels/schedules for PF-08052667 determined in Parts 1 and 2. Dose Optimization and Expansion Sasanlimab PF-08052667 monotherapy or in combination with BCG and/or sasanlimab at dose levels/schedules for PF-08052667 determined in Parts 1 and 2. Dose Optimization and Expansion BCG PF-08052667 monotherapy or in combination with BCG and/or sasanlimab at dose levels/schedules for PF-08052667 determined in Parts 1 and 2. Dose Optimization and Expansion PF-02921367 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 Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method PK: Maximum Observed Serum Concentration (Cmax) From the first day through 30-37 days after the last study treatment Cmax of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)
PK: Time to Reach Maximum Observed Serum Concentration (Tmax) From the first day through 30-37 days after the last study treatment Tmax of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)
PK: Minimum observed serum concentration (Ctrough) From the first day through 30-37 days after the last study treatment Ctrough of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)
PK: Area under the concentration-time curve (AUC) from time zero to last (AUC from time 0 to AUClast) From the first day through 30-37 days after the last study treatment AUClast of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)
PK: Half-life (t1/2) From the first day through 30-37 days after the last study treatment 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) Through 30-37 days after the last study treatment, up to approximately 2 years Incidence and titers of ADA and neutralizing antibody against PF-08052667
Duration of Complete Response (CR) in Part 1 and Part 2 participants only Through end of study and up to approximately 2 years Duration of CR is the time from first documentation of CR until the first occurrence of an Event-free survival (EFS) event
Complete Response Rate (CRR) in Part 1 and Part 2 participants only Through end of study and up to approximately 2 years CR rate is defined as the proportion of subjects achieving CR
Overall survival (OS) in Part 3 participants only Through end of study approximately 5 years from last participant enrollment Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause
Cystectomy-free survival in all Parts Through end of study and up to approximately 2 years Cystectomy-free survival is defined as the time from the first dose until cystectomy or death due to any cause, whichever occurs first
Event-free survival (EFS) in Part 1 and Part 2 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
Recurrence-free survival (RFS) in Part 1 and Part 2 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
Rate of cystectomy in all parts Through end of study and up to approximately 2 years Rate of cystectomy is defined as the proportion of participants who had a cystectomy while on study
Number of participants with adverse events (AEs) in Part 3 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 Part3 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
Trial Locations
- Locations (35)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
The University of Kansas - Clinical Research Center
🇺🇸Fairway, Kansas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Scroll for more (25 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States