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.
Active enrolling
United States, Australia, Canada, Italy, Korea, Republic of, Spain, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Disitamab vedotin monotherapy
Disitamab vedotin monotherapy
DRUG: disitamab vedotin
Given into the vein (IV, intravenous) every 2 weeksConfirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
Approximately 3 years
Number of participants with adverse events (AEs)
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 dose of DV; approximately 5 years
Number of participants with laboratories abnormalities
Through 30-37 days after the last dose of DV; approximately 5 years
Number of participants with dose alterations due to AEs
Approximately 5 years
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1
Approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause
Approximately 5 years
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
PFS is defined as the time from the start of study treatment to the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurs first
Approximately 5 years
Overall Survival (OS)
The time from the start of study treatment to the date of death due to any cause
Approximately 5 years
Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
Analyzed through cycle 2.
Approximately 1 month
PK parameter - Maximum concentration (Cmax)
Analyzed through end of treatment.
Through 30-37 days after the last dose of DV; approximately 5 years
PK parameter - Trough concentration (Ctrough)
Analyzed through end of treatment.
Through 30-37 days after the last dose of DV; approximately 5 years
Incidence of antidrug antibodies (ADAs)
Through 30-37 days after the last dose of DV; approximately 5 years
160
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.
NCT06003231
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