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)

Recruiting now · Phase 1/Phase 2

Conditions studied: Breast Neoplasms, Breast Cancer

In brief

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

Key facts

Study ID

NCT06686394

Run by

Merck Sharp & Dohme LLC

People needed

81

Starts

2025-02-26

Expected to finish

2030-04-18

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.