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New pill targets HER2 cancers in phase 2 trial

NCT ID NCT06581432

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 12 times

Summary

This study tests an oral drug called zongertinib in adults with advanced solid tumors that have HER2 mutations or overexpression and have not responded to prior treatment. Participants take one of two daily doses and continue as long as they benefit. Doctors regularly check tumor size and overall health to see if the drug shrinks tumors and how safe it is.

What this could mean

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

Active substance
zongertinib (a daily oral drug that blocks HER2, a protein that can fuel cancer growth)
What this could lead to
If successful, zongertinib could offer a new treatment option for people with advanced cancers that have HER2 changes and have stopped responding to other therapies.
What could go wrong
This is an early-phase (Phase 2) trial with no control group, so results are preliminary. The drug may not shrink tumors in many participants, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 588 people

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

Started

Oct 2024

Expected to finish

Dec 2028

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: * Patients aged ≥18 years * Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing) * Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours * Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options * Availability of archival tumour tissue sample to confirm HER2 status * Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further inclusion criteria apply. Exclusion criteria: * Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer or metastatic gastroesophageal adenocarcinoma * Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC) * Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs) * Previous or concomitant malignancies other than the one treated in this trial within the previous 3 years except the following effectively treated cancers: nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer on watchful waiting or active surveillance, and other effectively treated malignancies that are considered cured by local treatment * Uncontrolled or symptomatic brain or subdural metastases during screening * Known diagnosis of leptomeningeal disease * Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Solid tumours

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    89 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Università degli Studi della Campania Luigi Vanvitelli

    RECRUITING

    Naples, 80131, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • Aichi Cancer Center Hospital

    RECRUITING

    Aichi, Nagoya, 464-8681, Japan

  • Alaska Oncology and Hematology, LLC

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Alliance Cancer Specialists, PC, Wynnewood

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Anhui Provincial Cancer Hospital

    RECRUITING

    Hefei, 230001, China

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Asklepios Kliniken GmbH & Co. KGaA

    RECRUITING

    Hamburg, 22763, Germany

  • Az. Ospedaliere Umberto I di Ancona

    RECRUITING

    Ancona, 60020, Italy

  • BC Cancer Agency - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • BRCR Global

    RECRUITING

    Tamarac, Florida, 33321, United States

  • CTR Georges-François Leclerc

    RECRUITING

    Dijon, 21079, France

  • CTR Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Cancer Research South Australia

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Centro di riferimento Oncologico

    NOT_YET_RECRUITING

    Aviano (PN), 33081, Italy

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 12203, Germany

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Clínica Universidad de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Clínica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, 28027, Spain

  • Community MD Anderson Cancer Center - East Medical Oncology

    RECRUITING

    Indianapolis, Indiana, 46219, United States

  • Complejo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Cross Cancer Institute (University of Alberta)

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Fondazione Policlinico Universitario Campus Bio-medico

    NOT_YET_RECRUITING

    Rome, 00128, Italy

  • GenesisCare North Shore

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • HOP Timone

    RECRUITING

    Marseille, 13385, France

  • HOP la Milétrie

    RECRUITING

    Poitiers, 86000, France

  • Hammersmith Hospital

    NOT_YET_RECRUITING

    London, W12 0HS, United Kingdom

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, 450008, China

  • Hokkaido University Hospital

    RECRUITING

    Hokkaido, Sapporo, 060-8648, Japan

  • Hospital Clinico De Valencia (INCLIVA)

    NOT_YET_RECRUITING

    Valencia, 46010, Spain

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Duran i Reynals

    NOT_YET_RECRUITING

    Barcelona, 08908, Spain

  • Hospital Germans Trias i Pujol

    NOT_YET_RECRUITING

    Badalona, 08916, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Hunan Province Tumor Hospital

    NOT_YET_RECRUITING

    Changsha, 410013, China

  • INS Bergonie

    RECRUITING

    Bordeaux, 33000, France

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Illinois Cancer Specialists

    RECRUITING

    Arlington Heights, Illinois, 60005, United States

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Istituto Scientifico Romagnolo

    RECRUITING

    Meldola (FC), 47014, Italy

  • Japanese Foundation for Cancer Research

    RECRUITING

    Tokyo, Koto-ku, 135-8550, Japan

  • Justus-Liebig Universität Gießen

    RECRUITING

    Giessen, 35392, Germany

  • Karmanos Cancer Institute

    COMPLETED

    Detroit, Michigan, 48201, United States

  • Klinikum rechts der Isar der Technischen Universität München

    RECRUITING

    München, 81675, Germany

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, Fukuoka, 812-8582, Japan

  • Macquarie University

    RECRUITING

    Macquarie Park, New South Wales, 2109, Australia

  • Maryland Oncology Hematology, Columbia

    RECRUITING

    Columbia, Maryland, 21044, United States

  • McGill University Health Centre (MUHC)

    COMPLETED

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan-Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Nanjing Drum Tower Hospital

    NOT_YET_RECRUITING

    Nanjing, 210008, China

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, Chuo-ku, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Chiba, Kashiwa, 277-8577, Japan

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, 168583, Singapore

  • Nederlands Kanker Instituut

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Ninewells Hospital & Medical School

    RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Okayama University Hospital

    NOT_YET_RECRUITING

    Okayama, Okayama, 700-8558, Japan

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, Osaka, 541-8567, Japan

  • Oslo Universitetssykehus HF, Radiumhospitalet

    RECRUITING

    Oslo, N-0379, Norway

  • Pan American Center for Oncology Trials, LLC

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Peking University First Hospital

    RECRUITING

    Beijing, 100034, China

  • Precision NextGen Oncology

    RECRUITING

    Beverly Hills, California, 90212, United States

  • Presbyterian Healthcare Services

    RECRUITING

    Albuquerque, New Mexico, 87110, United States

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Radboud Universitair Medisch Centrum

    RECRUITING

    Nijmegen, 6525 GL, Netherlands

  • Samsung Medical Center

    RECRUITING

    Seoul, 135-710, South Korea

  • Sarah Cannon Research Institute at Mary Crowley

    RECRUITING

    Dallas, Texas, 75230, United States

  • Scripps Cancer Center Torrey Pines

    RECRUITING

    La Jolla, California, 92037, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • Shanghai East Hospital

    RECRUITING

    Shanghai, 200120, China

  • Shanghai GoBroad Cancer Hospital

    RECRUITING

    Shanghai, 200131, China

  • Shizuoka Cancer Center

    RECRUITING

    Shizuoka, Sunto-gun, 411-8777, Japan

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    RECRUITING

    Hangzhou, 310016, China

  • St John of God Subiaco Hospital

    RECRUITING

    Subiaco, Western Australia, 6008, Australia

  • Taylor Cancer Research Center

    RECRUITING

    Maumee, Ohio, 43537, United States

  • Texas Oncology - Plano West

    RECRUITING

    Plano, Texas, 75093, United States

  • The Christie Hospital

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, 330006, China

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

    NOT_YET_RECRUITING

    Wuhan, 430030, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, 430022, China

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

  • University of Arizona Comprehensive Cancer Center

    COMPLETED

    Tucson, Arizona, 85719, United States

  • Universität Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Mannheim GmbH

    RECRUITING

    Mannheim, 68167, Germany

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Virginia Cancer Specialists, PC

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06511, United States

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