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Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

ConditionsBreast NeoplasmsBreast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Uncontrolled or significant cardiovascular disease

Has any history of (noninfectious) interstitial lung disease (ILD)/ pneumonitis irrespective of steroid use or has current ILD or suspected ILD

Has clinically severe respiratory compromise

Has any history of or evidence of any current leptomeningeal disease

Trial design

Design model

Sequential

Treatments tested in this trial

  • Patritumab deruxtecan

    Biological/Vaccine

    Patritumab deruxtecan administered via IV infusion

  • Trastuzumab

    Biological/Vaccine

    Trastuzumab administered via IV infusion

  • Trastuzumab Biosimilar

    Biological/Vaccine

    Trastuzumab biosimilar administered via IV infusion

  • Pertuzumab

    Biological/Vaccine

    Pertuzumab administered via IV infusion

  • Tucatinib

    Biological/Vaccine

    Tucatinib administered as oral tablets

Treatment groups

181 Participants
are divided into 4 treatment groups
Group A: Part 1: Patritumab deruxtecan plus trastuzumabExperimental treatment 3 interventions
Group B: Part 1: Patritumab deruxtecan plus pertuzumab and trastuzumabExperimental treatment 4 interventions
Group C: Part 1: Patritumab deruxtecan plus trastuzumab and tucatinibExperimental treatment 4 interventions
Group D: Part 2: Patritumab deruxtecan plus pertuzumab and trastuzumabExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Part 1: Number of Participants Experiencing Dose-Limiting Toxicity (DLT)

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.

Time frame
Up to 21 days
2

Part 1: Number of Participants with One or More Adverse Events (AEs)

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.

Time frame
Up to approximately 36 months
3

Part 1: Number of Participants who Discontinue Study Intervention Due to an AE

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.

Time frame
Up to approximately 12 months
4

Part 2: Objective Response Rate (ORR)

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR)will be presented.

Time frame
Up to approximately 36 months

Secondary outcomes

1

Part 1: Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC)

Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan ADC.

Time frame
At designated time points (up to ~13 months)
2

Part 1: Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC

Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan ADC.

Time frame
At designated time points (up to ~13 months)
3

Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC

Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan ADC.

Time frame
At designated time points (up to ~13 months)
4

Part 1: Maximum Plasma Concentration (Cmax) of Total Patritumab Deruxtecan Antidrug Antibody (ADA)

Blood samples collected at designated time points will be used to determine the Cmax of total patritumab deruxtecan ADA.

Time frame
At designated time points (up to ~13 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator

Source ClinicalTrials.gov
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