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New oral drug targets Hard-to-Treat HER2 cancers

NCT ID NCT05593094

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental oral drug called ZN-A-1041, alone or with other cancer drugs, in people with HER2-positive advanced solid tumors (including breast cancer that has spread to the brain). The study aims to find safe doses and check how the drug works in the body. About 210 participants will take part across multiple phases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZN-A-1041 (an experimental oral drug) alone or combined with T-DM1, T-DXd, or other HER2-targeted therapies
What this could lead to
If successful, this could provide a new treatment option for people with HER2-positive advanced solid tumors, especially those with brain metastases.
What could go wrong
This is an early-phase trial (Phase 1/2) focused on safety and dosing, so it is not yet proven to work. Side effects are unknown, and the drug may not show enough benefit to move forward.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 6 months, as determined by the investigator * Histologically or cytologically confirmed with unresectable or metastatic HER2-positive advanced solid tumors * Must be relapsed or refractory after prior treatment for metastatic disease that included a taxane and trastuzumab or must have received first-line induction therapy for advanced disease a pertuzumab plus trastuzumab-based regimen or a T-DXd-based regimen * Participants with new, untreated, progressive, or stable brain metastases are eligible Exclusion Criteria: * Participation in any other clinical study involving an investigational drug or device within 4 weeks prior to the first dose of study treatment * Any intracranial lesion (brain metastasis) that requires immediate local therapy, such as surgery or radiation, or systemic corticosteroids at the time of enrollment

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Conditions

The condition(s) this trial relates to.

brain cancer HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors HER2-positive breast cancer

Contacts and locations

Locations

  • Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa

    Tucson, Arizona, 85712, United States

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24127, Italy

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Centre Georges Francois Leclerc

    Dijon, 21000, France

  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Clatterbridge Cancer Centre

    Liverpool, Merseyside, L69 3GL, United Kingdom

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University School of Medicine

    Durham, North Carolina, 27710, United States

  • EDOG - Institut Claudius Regaud - PPDS

    Toulouse, Haute-Garonne, 31059, France

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Magnago, Lombardy, 20020, Italy

  • Fundacion Instituto Valenciano de Oncologia (IVO)

    Valencia, 46009, Spain

  • Geelong Hospital

    Geelong, Victoria, 3220, Australia

  • Gustave Roussy

    Villejuif, 94800, France

  • Hospital Beata Maria Ana

    Madrid, 28007, Spain

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, LA Coruna, 15706, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal

    A Gudiña, Orense, 32540, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    Las Cabezas de San Juan, Sevilla, 41730, Spain

  • Hospital Universitario de Jaen

    Jaén, 23007, Spain

  • Institut Paoli-Calmettes

    Marseille, 13009, France

  • Institut de Cancerologie de l Ouest

    Saint-Herblain, 44805, France

  • Instituto Oncologico Dr. Rosell-Hospital Universitari Dexeus-Grupo Quironsalud

    Barcelona, 08028, Spain

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    Argentona, Barcelona, 08310, Spain

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS

    Parma, Emilia-Romagna, 43126, Italy

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4000, United States

  • Sunshine Hospital

    St Albans, Victoria, 3021, Australia

  • TOI Clinical Research

    Cerritos, California, 90703-2684, United States

  • The Christie

    Manchester, Lancashire, M20 4BX, United Kingdom

  • UCSF Helen Diller Family CCC

    San Francisco, California, 94158, United States

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109, United States

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