Breast Neoplasms, Breast Cancer
Conditions
Brief summary
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment
Detailed description
The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.
Interventions
BIOLOGICALPatritumab deruxtecan
Patritumab deruxtecan administered via IV infusion
BIOLOGICALTrastuzumab
Trastuzumab administered via IV infusion
BIOLOGICALTrastuzumab Biosimilar
Trastuzumab biosimilar administered via IV infusion
BIOLOGICALPertuzumab
Pertuzumab administered via IV infusion
BIOLOGICALTucatinib
Tucatinib administered as oral tablets
Sponsors
Merck Sharp & Dohme LLC
Daiichi Sankyo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer * Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention Arm 1: * Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting * Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment Arm 2: -Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting Arm 3: -Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Adverse Events (AEs) | Up to approximately 13 months | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented. |
| Number of Participants who Discontinue Study Intervention Due to an AE | Up to approximately 12 months | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented. |
| Number of Participants Experiencing Dose-Limiting Toxicity (DLT) | Up to 21 days | DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The number of participants who experience a DLT will be presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Total Patritumab Deruxtecan Antidrug Antibody (ADA) | At designated time points (up to ~13 months) | Blood samples collected at designated time points will be used to determine the Cmax of total patritumab deruxtecan ADA. |
| Trough Concentration (Ctrough) of Total Patritumab Deruxtecan ADA | At designated time points (up to ~13 months) | Blood samples collected at designated time points will be used to determine the Ctrough of total patritumab deruxtecan ADA. |
| Area Under the Plasma Concentration-Time Curve (AUC) of Total Patritumab Deruxtecan ADA | At designated time points (up to ~13 months) | Blood samples collected at designated time points will be used to determine the AUC of total patritumab deruxtecan ADA. |
| Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Free Payload | At designated time points (up to ~13 months) | Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan free payload. |
| Trough Concentration (Ctrough) of Patritumab Deruxtecan Free Payload | At designated time points (up to ~13 months) | Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan free payload. |
| Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC) | At designated time points (up to ~13 months) | Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan ADC. |
| Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan Free Payload | At designated time points (up to ~13 months) | Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan free payload. |
| Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC | At designated time points (up to ~13 months) | Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan ADC. |
| Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC | At designated time points (up to ~13 months) | Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan ADC. |
Countries
Canada, Israel, Japan, South Korea, United Kingdom, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed