A Phase 1 interventional study of PF-08052667 and Sasanlimab in Non-muscle Invasive Bladder Cancer, sponsored by Pfizer. Recruiting at 69 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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:
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.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
This study's planned enrollment of 294 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: PF-08052667 · Drug: PF-02921367
PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1
Drug: PF-08052667 · Drug: Sasanlimab · Drug: BCG · Drug: 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.
Drug: PF-08052667 · Drug: Sasanlimab · Drug: BCG · Drug: PF-02921367
PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash
Also known as: SGN-B6N
Sasanlimab will be administered as subcutaneous (SC) injection
Also known as: PF-06801591
BCG will be administered intravesical (IVe) instillation
PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation
Also known as: DDM
Number of participants with dose limiting toxicities (DLTs) in dose escalation in Part 1 and Part 2 participants only
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.
Time frame: Day of first dose (Day 1) Up to 21 days
Number of participants with adverse events (AEs) in Part 1 and Part 2 participants only
AEs as characterized by type, frequency, severity (CTCAE v5.0), seriousness, and relatedness to study drug(s).
Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with laboratory abnormalities in Part 1 and Part 2 participants only
Laboratory abnormalities as characterized by type, frequency, severity
Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Recurrence-free survival (RFS) in Part 3 participants only
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
Time frame: Through end of study and up to approximately 2 years
Event-free survival (EFS) in Part 3 participants only
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
Time frame: Through end of study and up to approximately 2 years
PK: Maximum Observed Serum Concentration (Cmax)
Cmax of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)
Time frame: From the first day through 30-37 days after the last study treatment
PK: Time to Reach Maximum Observed Serum Concentration (Tmax)
Tmax of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)
Time frame: From the first day through 30-37 days after the last study treatment
PK: Minimum observed serum concentration (Ctrough)
Ctrough of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)
Time frame: From the first day through 30-37 days after the last study treatment
PK: Area under the concentration-time curve (AUC) from time zero to last (AUC from time 0 to AUClast)
AUClast of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3)
Time frame: From the first day through 30-37 days after the last study treatment
PK: Half-life (t1/2)
Time frame: 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)
Incidence and titers of ADA and neutralizing antibody against PF-08052667
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
Duration of Complete Response (CR) in Part 1 and Part 2 participants only
Duration of CR is the time from first documentation of CR until the first occurrence of an Event-free survival (EFS) event
Time frame: Through end of study and up to approximately 2 years
Complete Response Rate (CRR) in Part 1 and Part 2 participants only
CR rate is defined as the proportion of subjects achieving CR
Time frame: Through end of study and up to approximately 2 years
Overall survival (OS) in Part 3 participants only
Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause
Time frame: Through end of study approximately 5 years from last participant enrollment
Cystectomy-free survival in all Parts
Cystectomy-free survival is defined as the time from the first dose until cystectomy or death due to any cause, whichever occurs first
Time frame: Through end of study and up to approximately 2 years
Event-free survival (EFS) in Part 1 and Part 2 participants only
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
Time frame: Through end of study and up to approximately 2 years
Recurrence-free survival (RFS) in Part 1 and Part 2 participants only
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
Time frame: Through end of study and up to approximately 2 years
Rate of cystectomy in all parts
Rate of cystectomy is defined as the proportion of participants who had a cystectomy while on study
Time frame: Through end of study and up to approximately 2 years
Number of participants with adverse events (AEs) in Part 3 participants only
AEs as characterized by type, frequency, severity (CTCAE v5.0), seriousness, and relatedness to study drug(s)
Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with laboratory abnormalities in Part3 participants only
Laboratory abnormalities as characterized by type, frequency, severity
Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Started Nov 2025 (actual). Primary completion is estimated for Jan 2030, 50 months after the start.
Of 24 phase 1 interventional studies under Non-Muscle Invasive Bladder Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 61. This study's planned 50 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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