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PF-08052667 | B6N is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, France, Israel, South Korea, Spain
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.
DRUG: PF-08052667
PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-washDRUG: PF-02921367
PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillationEXPERIMENTAL: Combination Therapy Dose Escalation
PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1
DRUG: PF-08052667
PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-washDRUG: Sasanlimab
Sasanlimab will be administered as subcutaneous (SC) injectionDRUG: BCG
BCG will be administered intravesical (IVe) instillationDRUG: PF-02921367
PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillationEXPERIMENTAL: 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.
DRUG: PF-08052667
PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-washDRUG: Sasanlimab
Sasanlimab will be administered as subcutaneous (SC) injectionDRUG: BCG
BCG will be administered intravesical (IVe) instillationDRUG: PF-02921367
PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillationEXCLUSION CRITERIA: 1. 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
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.
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).
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
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
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
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)
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)
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)
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)
From the first day through 30-37 days after the last study treatment
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)
Incidence and titers of ADA and neutralizing antibody against PF-08052667
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
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
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
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
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
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
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
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)
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
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
294
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT07206225
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