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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.
Active enrolling
United States, Australia, Canada, Italy, Korea, Republic of, Spain, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Dose Escalation - Previously treated advanced GC/GEJC or breast cancer
disitamab vedotin + tucatinib
DRUG: disitamab vedotin
Given into the vein (IV; intravenous)DRUG: tucatinib
300mg given twice daily by mouth (orally)EXPERIMENTAL: Cohort A monotherapy - HER2-low 2L or 3L breast cancer
disitamab vedotin monotherapy
DRUG: disitamab vedotin
Given into the vein (IV; intravenous)EXPERIMENTAL: Cohort A - HER2-low 2L or 3L breast cancer
disitamab vedotin + tucatinib
DRUG: disitamab vedotin
Given into the vein (IV; intravenous)DRUG: tucatinib
300mg given twice daily by mouth (orally)EXPERIMENTAL: Cohort B monotherapy - HER2+ 3L or higher breast cancer
disitamab vedotin monotherapy
DRUG: disitamab vedotin
Given into the vein (IV; intravenous)EXPERIMENTAL: Cohort B - HER2+ 3L or higher breast cancer
disitamab vedotin + tucatinib
DRUG: disitamab vedotin
Given into the vein (IV; intravenous)DRUG: tucatinib
300mg given twice daily by mouth (orally)EXPERIMENTAL: Cohort C monotherapy - HER2-low 2L GC/GEJC
disitamab vedotin monotherapy
DRUG: disitamab vedotin
Given into the vein (IV; intravenous)EXPERIMENTAL: Cohort C - HER2-low 2L GC/GEJC
disitamab vedotin + tucatinib
DRUG: disitamab vedotin
Given into the vein (IV; intravenous)DRUG: tucatinib
300mg given twice daily by mouth (orally)Number of participants with dose limiting toxicities DLTs) in dose escalation phase
Up to 28 days
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 days after the last study treatment; approximately 5 years
Number of participants with laboratory abnormalities
Through 30-37 days after the last study treatment: approximately 5 years
Number of participants with dose alterations
Through 30-37 days after the last study treatment: approximately 5 years
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 confirmed response (CR) or partial response (PR) according to RECIST v1.1.
Approximately 3 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
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
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
The time from randomization (or Cycle 1 Day 1 for participants in dose escalation phase) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.
Approximately 5 years
Overall survival (OS)
The time from randomization (or Cycle 1 Day 1 for participants in dose escalation phase) to the date of death due to any cause.
Approximately 5 years
Pharmacokinetic (PK) parameter - Maximum concentration (Cmax)
Through 30-37 days after the last study treatment; approximately 5 years
PK parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
Approximately 1 month
Incidence of anti-drug antibodies (ADAs) against disitamab vedotin
Through 30-37 days after the last study treatment; approximately 5 years
198
Sponsor: Seagen Inc.
Collaborator: RemeGen Co., Ltd.
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: