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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
PF-08046050 | SGN-CEACAM5C is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Canada, Netherlands, Spain, Sweden, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: PF-08046050
PF-08046050 monotherapy
DRUG: PF-08046050
Given into the vein (IV; intravenous)Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with laboratory abnormalities
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of dose modifications due to AEs
Through end of treatment up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
Up to 28 days
Number of participants with DLTs by dose level
Up to 28 days
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
PK endpoint
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Maximum concentration (Cmax)
PK endpoint
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax)
PK endpoint
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Trough concentration (Ctrough)
PK endpoint
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with antidrug antibodies (ADAs)
Through 30-37 days after the last study treatment, up to approximately 2 years
Objective response rate (ORR)
The objective response rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation in Solid Tumors (RECIST) v1.1.
Through end of study and up to approximately 2 years
Best response
The best response for a participant will be determined by the order of confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), not evaluable (NE) or not applicable (NA) per RECIST v1.1.
Through end of study and up to approximately 2 years
Duration of response (DOR)
DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST v1.1 or to death due to any cause
Through end of study and up to approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from start of SGN-CEACAM5C to first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause, whichever comes first
Through end of study and up to approximately 2 years
Overall survival (OS)
OS is defined as the time from start of SGN-CEACAM5C to date of death due to any cause
Through end of study and up to approximately 2 years
410
Sponsor: Seagen Inc.
Collaborator: Sanofi
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: