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-08046054 | SGN-PDL1V is an investigational compound. Its safety and efficacy have not been established
Active enrolling
United States, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: PF-08046054 Monotherapy
PF-08046054 monotherapy
DRUG: PF-08046054
Given into the vein (IV; intravenously)EXPERIMENTAL: PF-08046054 Combination Therapy
PF-08046054 + pembrolizumab
DRUG: PF-08046054
Given into the vein (IV; intravenously)DRUG: pembrolizumab
200 mg once every 3 weeks given into the vein (IV; intravenously)Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Through approximately 90 days after last study treatment; up to 3 years
Number of participants with laboratory abnormalities
Through approximately 90 days after last study treatment; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Through the first cycle of study treatment; approximately 1 month
Number of participants with DLTs by dose level
Through the first cycle of study treatment; approximately 1 month
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment
The proportion of participants with a partial response (PR) or complete response (CR) which is subsequently confirmed per RECIST v1.1 as assessed by the investigator.
Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
The time from the start of the first documentation of objective tumor response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or to death due to any cause.
Up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause.
Up to approximately 3 years
Overall survival (OS)
The time from the start of study treatment to death due to any cause.
Up to approximately 3 years
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment; up to approximately 3 years
Incidence of anti-drug antibodies (ADAs)
To be summarized using descriptive statistics
Through 30-37 days after last study treatment; up to approximately 3 years
438
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.
NCT05208762
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