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Recruiting Phase 1/2

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 · tracked via the Priya Life Science Israel tracker
Phase
Phase 1/2
Started
2025-02-26
Last updated
2026-05-22

Condition(s) studied

Breast NeoplasmsBreast Cancer

Investigational drug(s) / intervention(s)

Patritumab deruxtecan →Trastuzumab →Trastuzumab Biosimilar →Pertuzumab →Tucatinib →

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (18)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06686394 on ClinicalTrials.gov ↗ ← All trials in Israel