Recruiting
Phase 1
Phase 2

Patritumab Deruxtecan, Anticancer Agents

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06686394

Conditions

Breast Neoplasms

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patritumab deruxtecan

Trastuzumab

Trastuzumab Biosimilar

Pertuzumab

Tucatinib

Study Details

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

Conditions

Breast Neoplasms

Breast Cancer

Study ID

NCT06686394

Start date

Feb 26, 2025

Status verified date

May, 2026

Completion date

Apr 18, 2030

Anticipated

Primary completion date

Apr 18, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

81 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patritumab deruxtecan plus trastuzumab

Participants receive patritumab deruxtecan intravenous (IV) infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.

experimental: Patritumab deruxtecan plus pertuzumab and trastuzumab

Participants receive patritumab deruxtecan IV infusion, pertuzumab IV infusion, and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.

experimental: Patritumab deruxtecan plus trastuzumab and tucatinib

Participants receive patritumab deruxtecan IV infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks), and tucatinib is administered orally twice daily for each 21-day cycle, until disease progression, intolerable toxicity, or investigator decision.

Interventions

Patritumab deruxtecan

Patritumab deruxtecan administered via IV infusion

Trastuzumab

Trastuzumab administered via IV infusion

Trastuzumab Biosimilar

Trastuzumab biosimilar administered via IV infusion

Pertuzumab

Pertuzumab administered via IV infusion

Tucatinib

Tucatinib administered as oral tablets

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Colorado Anschutz Medical Campus ( Site 0057)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-848-1030

Dana-Farber Cancer Institute ( Site 0050)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

877-338-7425

Rutgers Cancer Institute of New Jersey ( Site 0052)

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Study Coordinator

732-235-2465

Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Study Coordinator

864-455-3600

Inova Schar Cancer Institute ( Site 0051)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

571-472-4724

Kingston General Hospital ( Site 0061)

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Study Coordinator

6135336541

Princess Margaret Cancer Centre ( Site 0001)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

416-946-4501

Centre Hospitalier de l'Université de Montréal ( Site 0004)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Study Coordinator

(514)890-8000 x20737

Jewish General Hospital ( Site 0003)

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Study Coordinator

514-340-8222

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-05-22.