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)

Официальное название

HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Обзор

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

Подробное описание

The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.

Вмешательства

• Биопрепарат Patritumab deruxtecan
  Patritumab deruxtecan administered via IV infusion
• Биопрепарат Trastuzumab
  Trastuzumab administered via IV infusion
• Биопрепарат Trastuzumab Biosimilar
  Trastuzumab biosimilar administered via IV infusion
• Биопрепарат Pertuzumab
  Pertuzumab administered via IV infusion
• Биопрепарат Tucatinib
  Tucatinib administered as oral tablets

Первичные конечные точки

• Number of Participants Experiencing Dose-Limiting Toxicity (DLT) [Срок оценки: Up to 21 days]
• Number of Participants with One or More Adverse Events (AEs) [Срок оценки: Up to approximately 13 months]
• Number of Participants who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 12 months]

Вторичные конечные точки (9)

• Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC) [Срок оценки: At designated time points (up to ~13 months)]
• Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC [Срок оценки: At designated time points (up to ~13 months)]
• Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC [Срок оценки: At designated time points (up to ~13 months)]
• Maximum Plasma Concentration (Cmax) of Total Patritumab Deruxtecan Antidrug Antibody (ADA) [Срок оценки: At designated time points (up to ~13 months)]
• Trough Concentration (Ctrough) of Total Patritumab Deruxtecan ADA [Срок оценки: At designated time points (up to ~13 months)]
• Area Under the Plasma Concentration-Time Curve (AUC) of Total Patritumab Deruxtecan ADA [Срок оценки: At designated time points (up to ~13 months)]
• Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Free Payload [Срок оценки: At designated time points (up to ~13 months)]
• Trough Concentration (Ctrough) of Patritumab Deruxtecan Free Payload [Срок оценки: At designated time points (up to ~13 months)]
• Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan Free Payload [Срок оценки: At designated time points (up to ~13 months)]

Критерии участия

Критерии включения

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.

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• Uncontrolled or significant cardiovascular disease
• History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease
• Has clinically severe respiratory compromise
• Has any history of or evidence of any current leptomeningeal disease
• Has clinically significant corneal disease
• Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
• HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Known additional malignancy that is progressing or has required active treatment within the past 3 years
• Evidence of spinal cord compression or brain metastases
• Has an active infection requiring systemic therapy
• Concurrent active HBV and HCV infection
• Has had major surgical procedure (excluding placement of vascular access) less than 28 days

Arm 3 ONLY

\- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• University of Colorado Anschutz Medical Campus ( Site 0057) — Aurora
• Dana-Farber Cancer Institute ( Site 0050) — Boston
• Rutgers Cancer Institute of New Jersey ( Site 0052) — New Brunswick
• Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053) — Greenville
• Inova Schar Cancer Institute ( Site 0051) — Fairfax

Канада · 4 центра

• Kingston General Hospital ( Site 0061) — Kingston
• Princess Margaret Cancer Centre ( Site 0001) — Toronto
• Centre Hospitalier de l'Université de Montréal ( Site 0004) — Montreal
• Jewish General Hospital ( Site 0003) — Montreal

Израиль · 3 центра

• Rambam Health Care Campus ( Site 0011) — Haifa
• Rabin Medical Center ( Site 0012) — Petah Tikva
• Sheba Medical Center ( Site 0010) — Ramat Gan

Великобритания · 3 центра

• University College London Hospital ( Site 0041) — London
• The Beatson West of Scotland Cancer Centre ( Site 0043) — Glasgow
• St Bartholomew s Hospital ( Site 0040) — London

South Korea · 2 центра

• Seoul National University Hospital ( Site 0030) — Seoul
• Asan Medical Center ( Site 0031) — Seoul

Япония · 1 центр

• Nagoya City University Hospital ( Site 0020) — Nagoya

Идентификаторы

NCT: NCT06686394 · 1022-009 · MK-1022-009 · jRCT2041250022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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