A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Purpose
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.
Condition
- Non-muscle Invasive Bladder Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18 years of age or older (or the minimum age of consent per local regulations) 2. 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 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. 4. Have refused or are ineligible or not appropriate for radical cystectomy 5. 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 6. ECOG PS 0 or 1
Exclusion Criteria
- Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed 2. Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol 3. Participants with active, uncontrolled infection as specified in the protocol
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Birmingham, Alabama 35249
Birmingham, Alabama 35294
Ruskin, Florida 33570
Tampa, Florida 33607
Tampa, Florida 33612
Tampa, Florida 33612
Tampa, Florida 33612
Wesley Chapel, Florida 33544
Atlanta, Georgia 30308
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Iowa City, Iowa 52242
Fairway, Kansas 66205
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Overland Park, Kansas 66211
Westwood, Kansas 66205
New York, New York 10029
Syracuse, New York 13202
Syracuse, New York 13210
Syracuse, New York 13215
Durham, North Carolina 27710
Durham, North Carolina 27710
Durham, North Carolina 27710
Myrtle Beach, South Carolina 295724607
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29579
Nashville, Tennessee 37209
Dallas, Texas 75235
Dallas, Texas 75390
Dallas, Texas 75390
Dallas, Texas 75390
Dallas, Texas 75390
San Antonio, Texas 78229
San Antonio, Texas 78229
San Antonio, Texas 78240
More Details
- Status
- Recruiting
- Sponsor
- Pfizer