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.
Felmetatug vedotin is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Canada, Germany, Italy, Spain, United Kingdom
EXPERIMENTAL: SGN-B7H4V
SGN-B7H4V monotherapy
DRUG: SGN-B7H4V
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 30 days after last study treatment, up to approximately 3 years
Number of participants with laboratory abnormalities
Through 30-37 days after last study treatment, up to approximately 3 years
Number of participants with dose limiting toxicities (DLTs)
Up to 28 days
Confirmed objective response rate (ORR) by investigator assessment
The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator.
Up to approximately 3 years
Complete response rate (CRR)
The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.
Up to approximately 3 years
Duration of response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.
Up to approximately 3 years
Progression-free survival (PFS)
The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
Up to approximately 3 years
Overall survival (OS)
The time from the start of any study treatment to the date of death due to any cause.
Up to approximately 3 years
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 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 - Time to maximum concentration (Tmax)
To be summarized using descriptive statistics.
Through 30-37 days after last study treatment, up to approximately 3 years
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 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 antidrug antibodies (ADAs)
To be summarized using descriptive statistics.
Through 30-37 days after last study treatment, up to approximately 3 years
430
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.
NCT05194072
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