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-08046053, SGN-EGFRd2 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: SGN-EGFRd2
SGN-EGFRd2 monotherapy
DRUG: SGN-EGFRd2
Given into the vein (IV; intravenously)Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Through 90 days after last study treatment, up to approximately 1 year
Number of participants with laboratory abnormalities
Through 30-37 days after last study treatment, up to approximately 1 year
Number of participants with dose limiting toxicities (DLTs)
Up to 35 days
Number of participants with DLTs by dose level
Up to 35 days
Number of participants with antidrug antibodies (ADAs)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, up to approximately 1 year
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Time to maximum concentration (Tmax)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Apparent terminal half-life (t1/2)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, up to approximately 1 year
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment, up to approximately 1 year
Objective response rate (ORR)
ORR is defined as the proportion of participants with an objective response per Response Evaluation in Solid Tumors (RECIST) 1.1 per investigator. A participant is determined to have an objective response if, based on RECIST 1.1, they achieve a complete response (CR) or partial response (PR) after initiation of treatment and at or prior to the EOT disease assessment.
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 1.1 or to death due to any cause, whichever comes first
Up to approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from start of SGN-EGFRd2 to first documentation of disease progression or death due to any cause, whichever comes first
Up to approximately 2 years
Overall survival (OS)
OS is defined as the time from start of SGN-EGFRd2 to date of death due to any cause
Up to approximately 3 years
275
Sponsor: Seagen Inc.
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.
NCT05983133
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