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New treatment option for Non-muscle Invasive Bladder Cancer
Official title A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
ClinicalTrials.gov ID: NCT07206225
What this study is testing
What is PF-08052667?
PF-08052667 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for non-muscle invasive bladder cancer.
Also referred to as SGN-B6N.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older (or the minimum age of consent per local regulations)
- Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder defined according to the WHO grading system as carcinoma...
- 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...
- Have refused or are ineligible or not appropriate for radical cystectomy
- Tissue Requirement: Available tumor tissue within the last 6 months. On-treatment tumor biopsy is optional, unless mandated based on emerging data...
You likely can't join if
- Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed
- Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol
- Participants with active, uncontrolled infection as specified in the protocol
See the full eligibility criteria
- 18 years of age or older (or the minimum age of consent per local regulations)
- 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...
- 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.
- Have refused or are ineligible or not appropriate for radical cystectomy
- 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
- ECOG PS 0 or 1
- Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed
- Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol
- Participants with active, uncontrolled infection as specified in the protocol
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Orlando, Florida, United States
- Ruskin, Florida, United States
- Tampa, Florida, United States
- Wesley Chapel, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Fairway, Kansas, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Westwood, Kansas, United States
- New York, New York, United States
- Syracuse, New York, United States
- Durham, North Carolina, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Villejuif, VAL DE Marne, France
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Orlando, Florida, United States; Ruskin, Florida, United States; Tampa, Florida, United States; Wesley Chapel, Florida, United States; Atlanta, Georgia, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.