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Looking for participantsPhase1/Phase2

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

NCT ID: NCT06686394

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Patritumab deruxtecan (biological), Trastuzumab (biological), Trastuzumab Biosimilar (biological), Pertuzumab (biological)
How long the study runs
Study runs about 62 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
181
Started
2025-02-26
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for breast neoplasms
  • • Phase1/Phase2 - 181 participants
  • • Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast neoplasms

Where?

  • • London - University College London Hospital ( Site 0041)
  • • Glasgow - The Beatson West of Scotland Cancer Centre ( Site 0043)
  • • London - St Bartholomew s Hospital ( Site 0040)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.

Breast NeoplasmsBreast Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2

Treatment history

Treatments you must have had:

  • ✓ well-controlled HIV on antiretroviral therapy (ART)

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Has confirmed by a biopsy HER2+ that has grown locally unresectable breast cancer or that has spread breast cancer
  • ✓Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
  • ✓Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
  • ✓activity scale (ECOG) performance status 0 to 1 within 7 days before start of study intervention

Who cannot take part

  • ✗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...
  • ✗Has clinically severe respiratory compromise
  • ✗Has any history of or evidence of any current leptomeningeal disease
See the full 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

Where Is This Study? (3 UK sites)

University College London Hospital ( Site 0041)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442034472930

The Beatson West of Scotland Cancer Centre ( Site 0043)

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441413017000

St Bartholomew s Hospital ( Site 0040)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442073777000

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10