RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06686394

Registry updated: 2026-10-06

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Description

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

Interventions

Patritumab deruxtecan (Biological)
Patritumab deruxtecan administered via IV infusion
Trastuzumab (Biological)
Trastuzumab administered via IV infusion
Trastuzumab Biosimilar (Biological)
Trastuzumab biosimilar administered via IV infusion
Pertuzumab (Biological)
Pertuzumab administered via IV infusion
Tucatinib (Biological)
Tucatinib administered as oral tablets

Eligibility criteria

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 Part 1 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 Part 1 Arm 2: -Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting Part 1 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. Part 2 : Has not received prior systemic therapy (including T-DXd) for recurrent locally advanced or metastatic breast cancer (mBC). Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * 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 * 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 * Part 1: Evidence of spinal cord compression or brain metastases * Part 2: Evidence of spinal cord compression or brain/CNS 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 Part1: 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

Conditions

Breast Neoplasms Breast Cancer

Locations

University of Colorado Anschutz Medical Campus ( Site 0057) — Aurora, Colorado, United States
Dana-Farber Cancer Institute ( Site 0050) — Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey ( Site 0052) — New Brunswick, New Jersey, United States
Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053) — Greenville, South Carolina, United States
Inova Schar Cancer Institute ( Site 0051) — Fairfax, Virginia, United States
Kingston General Hospital ( Site 0061) — Kingston, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0001) — Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0004) — Montreal, Quebec, Canada
Jewish General Hospital ( Site 0003) — Montreal, Quebec, Canada
Rambam Health Care Campus ( Site 0011) — Haifa, Israel
Rabin Medical Center ( Site 0012) — Petah Tikva, Israel
Sheba Medical Center ( Site 0010) — Ramat Gan, Israel
Nagoya City University Hospital ( Site 0020) — Nagoya, Aichi-ken, Japan
Seoul National University Hospital ( Site 0030) — Seoul, South Korea
Asan Medical Center ( Site 0031) — Seoul, South Korea
University College London Hospital ( Site 0041) — London, Camden, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 0043) — Glasgow, Glasgow City, United Kingdom
St Bartholomew s Hospital ( Site 0040) — London, London, City of, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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