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PF-08634404 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Australia, China, Japan, Puerto Rico
for more information at clinicaltrials.gov
EXPERIMENTAL: Cohort A
Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy.
BIOLOGICAL: PF-08634404
Concentrate for solution for Infusion.EXPERIMENTAL: Cohort B
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin
BIOLOGICAL: PF-08634404
Concentrate for solution for Infusion.BIOLOGICAL: Enfortumab Vedotin
Powder for concentrate for solution for infusionConfirmed Objective Response Rate (ORR) by investigator
ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator.
Up to approximately 3 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention.
Through 90 days after the last study intervention; Up to approximately 3 years
Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B
The number of participants who experienced DLTs in participants receiving PF-08634404 in combination with EV.
Through 90 days after the last study intervention; Up to approximately 3 years
Duration of Response (DOR) per RECIST v1.1 by investigator
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
Up to approximately 3 years
Overall Survival (OS)
Overall survival defined as the time from the date of C1D1 to the date of death due to any cause.
Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0)
Through 90 days after the last study intervention; Up to approximately 3 years
Pharmacokinetics (PK): Serum concentration of PF-08634404
To characterize the pharmacokinetics (PK) of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC.
Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
To evaluate the immunogenicity of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC.
Up to 37 days after the last dose of treatment
132
Sponsor: Pfizer
Collaborator: Astellas Pharma Inc
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.
NCT07421700
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