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)

NCT06686394 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: 1022-009MK-1022-009jRCT2041250022
• Study Type: interventional
• Target: 81
• Locations: 6 countries
• Sites: 17

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 Cancer; Breast Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 21 days

• 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.

  Up to approximately 13 months

• 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.

  Up to approximately 12 months

Secondary Outcomes (9)

• Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC)

  At designated time points (up to ~13 months)

• Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC

  At designated time points (up to ~13 months)

• Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC

  At designated time points (up to ~13 months)

• Maximum Plasma Concentration (Cmax) of Total Patritumab Deruxtecan Antidrug Antibody (ADA)

  At designated time points (up to ~13 months)

• Trough Concentration (Ctrough) of Total Patritumab Deruxtecan ADA

  At designated time points (up to ~13 months)

Study Arms (3)

Patritumab deruxtecan plus trastuzumab

EXPERIMENTAL

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.

Biological: Patritumab deruxtecan; Biological: Trastuzumab; Biological: Trastuzumab Biosimilar

Patritumab deruxtecan plus pertuzumab and trastuzumab

EXPERIMENTAL

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.

Biological: Patritumab deruxtecan; Biological: Trastuzumab; Biological: Trastuzumab Biosimilar; Biological: Pertuzumab

Patritumab deruxtecan plus trastuzumab and tucatinib

EXPERIMENTAL

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.

Biological: Patritumab deruxtecan; Biological: Trastuzumab; Biological: Trastuzumab Biosimilar; Biological: Tucatinib

Interventions

Trastuzumab BIOLOGICAL

Trastuzumab administered via IV infusion

Also known as: Herceptin®

Patritumab deruxtecan plus pertuzumab and trastuzumab; Patritumab deruxtecan plus trastuzumab; Patritumab deruxtecan plus trastuzumab and tucatinib

Trastuzumab Biosimilar BIOLOGICAL

Trastuzumab biosimilar administered via IV infusion

Also known as: Trazimera®, Ogivri®, Herzuma®, Ontruzant®, Kanjinti®, Hercessi®

Patritumab deruxtecan plus pertuzumab and trastuzumab; Patritumab deruxtecan plus trastuzumab; Patritumab deruxtecan plus trastuzumab and tucatinib

Pertuzumab BIOLOGICAL

Pertuzumab administered via IV infusion

Patritumab deruxtecan plus pertuzumab and trastuzumab

Tucatinib BIOLOGICAL

Tucatinib administered as oral tablets

Patritumab deruxtecan plus trastuzumab and tucatinib

Patritumab deruxtecan BIOLOGICAL

Patritumab deruxtecan administered via IV infusion

Also known as: MK-1022, HER3-DXd, U3-1402

Patritumab deruxtecan plus pertuzumab and trastuzumab; Patritumab deruxtecan plus trastuzumab; Patritumab deruxtecan plus trastuzumab and tucatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Daiichi Sankyo: collaborator

Study Sites (17)

Dana-Farber Cancer Institute ( Site 0050)

Boston, Massachusetts, 02215, United States

RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 0052)

New Brunswick, New Jersey, 08901, United States

RECRUITING

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

Greenville, South Carolina, 29605, United States

RECRUITING

Inova Schar Cancer Institute ( Site 0051)

Fairfax, Virginia, 22031, United States

RECRUITING

Kingston General Hospital ( Site 0061)

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Princess Margaret Cancer Centre ( Site 0001)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

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

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Jewish General Hospital ( Site 0003)

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Rambam Health Care Campus ( Site 0011)

Haifa, 3109601, Israel

RECRUITING

Rabin Medical Center ( Site 0012)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 0010)

Ramat Gan, 5265601, Israel

RECRUITING

Nagoya City University Hospital ( Site 0020)

Nagoya, Aichi-ken, 467-8602, Japan

RECRUITING

Seoul National University Hospital ( Site 0030)

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center ( Site 0031)

Seoul, 05505, South Korea

RECRUITING

University College London Hospital ( Site 0041)

London, Camden, NW1 2PG, United Kingdom

RECRUITING

The Beatson West of Scotland Cancer Centre ( Site 0043)

Glasgow, Glasgow City, G12 0YN, United Kingdom

RECRUITING

St Bartholomew s Hospital ( Site 0040)

London, London, City of, EC1A 7BE, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Breast Neoplasms

Interventions

patritumab deruxtecan; Trastuzumab; Ogivri; Ontruzant; pertuzumab; tucatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: February 26, 2025
• Primary Completion (Estimated): April 18, 2030
• Study Completion (Estimated): April 18, 2030
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (4); JP (1); IL (3); GB (3); US (4); KR (2)