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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-08046045, SGN-35T is an investigational compound. Its safety and efficacy have not been established
Active enrolling
United States, Spain
EXPERIMENTAL: SGN-35T
SGN-35T monotherapy
DRUG: SGN-35T
Given into the vein (IV; intravenously)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 last study treatment, approximately 1 year
Number of participants with laboratory abnormalities
Through 30-37 days after last study treatment, approximately 1 year
Number of participants with dose modifications due to AEs
Up to approximately 1 year
Number of participants with dose-limiting toxicities (DLTs)
Up to 21 days
Number of participants with DLTs by dose level
Up to 21 days
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, approximately 1 year
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, approximately 1 year
PK parameter - Time to Cmax (Tmax)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, approximately 1 year
Number of participants with antidrug antibodies (ADA)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, approximately 1 year
Objective response rate (ORR) as assessed by the investigator
A subject is determined to have an objective response if, based on disease-specific assessment criteria, they achieve a complete response (CR) or partial response (PR) as assessed by the investigator. The ORR is defined as the percentage of participants with an objective response.
Up to approximately 1 year
Complete response (CR) rate as assessed by the investigator
CR rate is defined as the percentage of subjects with CR.
Up to approximately 1 year
Duration of response (DOR)
DOR is defined as the time from the start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per disease-specific assessment criteria as assessed by the investigator or to death due to any cause, whichever comes first.
Up to approximately 1 year
110
Sponsor: Seagen Inc.
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: