An Integrin β6-targeted antibody-drug conjugate optimized for intravesical delivery to treat non-muscle invasive bladder cancer.
Christopher M Carosino, Devra J Olson, Rebecca C Mazahreh...
https://pubmed.ncbi.nlm.nih.gov/42008114Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID07206225
A Phase 1 Study to Evaluate Safety, Tolerability, and Antitumor Activity of PF-08052667 Alone and with BCG and/or Sasanlimab in Adults with Bladder Cancer
Led by Pfizer · Updated on 2026-04-21
294
Participants Needed
47
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how a new medicine called PF-08052667 works alone or combined with Bacillus Calmette Guerin (BCG) and/or sasanlimab in adults with a kind of bladder cancer called non-muscle invasive bladder cancer. This cancer has not spread into the muscle layer but is likely to return or grow. The study includes people whose cancer has come back or not improved after standard treatments like BCG, or those who cannot have these treatments based on their doctor's opinion. The study is a phase 1 trial focused on safety, tolerability, and antitumor activity. The study has three parts. Part 1 tests PF-08052667 alone at increasing doses in patients whose disease worsened after standard treatments. Part 2 tests PF-08052667 combined with BCG and/or sasanlimab at fixed doses in similar patients. Part 3 evaluates PF-08052667 alone or with BCG and/or sasanlimab at optimized doses in patients, including those who never had standard treatments. PF-08052667 is given as an intravesical infusion directly into the bladder on days 1, 8, and 15 of a 21-day cycle. Sasanlimab is given by injection under the skin. Treatment continues until a participant stops, is asked to leave, or for up to about 2 years. Participants will have various assessments including monitoring for side effects, laboratory tests, and tumor tissue sampling. Researchers will track safety measures like dose limiting toxicities and adverse events, and effectiveness outcomes such as recurrence-free and event-free survival. Long-term follow-up will continue after treatment ends until loss to follow-up, death, or study completion. The total participation time varies per person depending on treatment duration and follow-up.
CONDITIONS
Brief Title
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older (or minimum age per local regulations)
- Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder (including carcinoma in situ with or without concurrent T1/Ta papillary disease)
- For BCG unresponsive or exposed cohorts, persistent or recurrent disease after at least 5 of 6 doses of BCG induction therapy
- Refused or ineligible for radical cystectomy
- Available tumor tissue within the last 6 months
- ECOG performance status of 0 or 1
You will not qualify if you...
- Receiving other anti-cancer therapy for non-muscle invasive bladder cancer
- Prior radiation therapy to the bladder
- Renal or liver impairment and hematologic abnormalities as defined in the protocol
- Active, uncontrolled infections as specified in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 21-day cycles
Participants receive PF-08052667 alone or in combination with BCG and/or sasanlimab through intravesical instillation and/or subcutaneous injection in 21-day cycles.
Visits on Day 1, 8, and 15 of each 21-day cycle
Follow-up
Duration - Up to approximately 2 years after last treatment
Participants are monitored for safety, adverse events, and disease outcomes after the last study treatment.
Regular follow-up visits up to 2 years
Trial Site Locations
Total: 47 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Not Yet Recruiting
3
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
4
AdventHealth Orlando
Orlando, Florida, United States, 32803
Not Yet Recruiting
5
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States, 33570
Not Yet Recruiting
6
Moffitt Cancer Center - International Plaza
Tampa, Florida, United States, 33607
Not Yet Recruiting
7
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States, 33612
Not Yet Recruiting
8
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
9
Moffitt McKinley Hospital
Tampa, Florida, United States, 33612
Not Yet Recruiting
10
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States, 33544
Not Yet Recruiting
11
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
12
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
14
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Not Yet Recruiting
15
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Not Yet Recruiting
16
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
17
The University of Kansas - Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
18
The University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, United States, 66160
Actively Recruiting
19
The University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Actively Recruiting
20
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, United States, 66160
Actively Recruiting
21
The University of Kansas Hospital - Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
22
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States, 66205
Actively Recruiting
23
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
24
Upstate Specialty Services at Harrison Center
Syracuse, New York, United States, 13202
Not Yet Recruiting
25
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Not Yet Recruiting
26
SUNY Upstate Medical University-Community Campus
Syracuse, New York, United States, 13215
Not Yet Recruiting
27
Biorepository and Precision Pathology Center (BRPC)
Durham, North Carolina, United States, 27710
Actively Recruiting
28
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
29
Substrate Services Core Research Support (SSCRS)
Durham, North Carolina, United States, 27710
Actively Recruiting
30
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States, 295724607
Actively Recruiting
31
AUC Urologists, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
32
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
33
Parkway Surgery Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
34
Coastal Eye Group
Myrtle Beach, South Carolina, United States, 29579
Actively Recruiting
35
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Actively Recruiting
36
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
37
Baptist M&S Imaging (Medical Center)
San Antonio, Texas, United States, 78229
Actively Recruiting
38
USA Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
39
MCOA Eye Associates
San Antonio, Texas, United States, 78240
Actively Recruiting
40
Gustave Roussy
Villejuif, VAL DE Marne, France, 94800
Not Yet Recruiting
41
Rabin Medical Center
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
42
Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Actively Recruiting
43
Hadassah Medical Center
Jerusalem, Jerusalem, Israel, 9112001
Actively Recruiting
44
Samsung Medical Center
Seoul, Seoul Teukbyeolsi [seoul], South Korea, 06351
Not Yet Recruiting
45
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
Not Yet Recruiting
46
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi, South Korea, 03722
Not Yet Recruiting
47
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
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Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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