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New pill combo aims to shrink Hard-to-Treat HER2 cancers

NCT ID NCT06324357

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 17, 2026 · Updated 7 times

Summary

This study tests an experimental oral drug called zongertinib, which blocks HER2, a protein that fuels cancer growth. It is given alone or with other cancer drugs to adults with advanced HER2+ breast, stomach, or colorectal cancer that has spread and not responded to prior treatment. The trial has two parts: first finding a safe dose, then testing how well the drug shrinks tumors. About 768 participants will take part across multiple sites.

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 HER2 inhibitor) combined with other cancer drugs
What this could lead to
If successful, this could provide a new treatment option for people with advanced HER2+ cancers that have stopped responding to current therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or may cause unexpected side effects. The results may not apply to all patients.

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 768 people

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

Started

Jun 2024

Expected to finish

Jan 2029

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 ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF) * Cohorts A to K and Cohort O: Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC). * Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression/amplification according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) gastric cancer guidelines and according to the result of local testing. * For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue * History of prior treatment lines in palliative setting: * For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K and O documented investigator assessed progression after HER2-directed treatment for unresectable locally advanced or metastatic disease (For Cohorts D, H, I (I-ext), J (J-ext) - patients must have been pretreated with trastuzumab deruxtecan (T-DXd) and have progressed or have been intolerant to previous T-DXd). * For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy. Patients must have had at least one prior line of therapy for locally advanced unresectable disease or metastatic disease (adjuvant and neoadjuvant therapy excluded) and documented disease progression or recurrence of disease during or following their latest line of therapy. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival. * Presence of at least one measurable lesion according to RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * Adequate organ function based on laboratory values Further inclusion criteria apply. Exclusion criteria: * Previous treatment with: * Any small molecule HER2 inhibitor in the palliative setting in Cohorts D, E, F, H, L, L-ext, M, and N. In Cohort D allowed in up to 15 patients in each dose level (DL). * T-DXd in Cohorts E and F. In Cohort E allowed in up to 15 patients in each DL. * trastuzumab emtansine (T-DM1) in the palliative setting in Cohort D and H. In Cohort H allowed in up to 15 patients in each DL. * Capecitabine in Cohort D and H. In Cohort D allowed in up to 15 patients in each DL * Presence of uncontrolled and/or symptomatic brain metastases, or leptomeningeal disease * Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) \>470 msec. * Any factors that increase the risk of QT interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age. * Ejection fraction \<50% or the lower limit of normal of the institutional standard within 28 days prior to randomization * History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus breast cancer breast carcinoma breast neoplasm colorectal cancer colorectal neoplasm esophageal adenocarcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma HER2 positive breast carcinoma

As listed by the trial registrant

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

Colorectal cancer Esophageal adenocarcinoma Gastroesophageal junction adenocarcinoma Metastatic breast cancer Metastatic gastric adenocarcinoma

How to take part

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

  1. The places running it

    104 sites in 10 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

  • Aichi Cancer Center Hospital

    RECRUITING

    Aichi, Nagoya, 464-8681, Japan

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Asklepios Kliniken GmbH & Co. KGaA

    RECRUITING

    Hamburg, 22763, Germany

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliero Universitaria delle Marche

    RECRUITING

    Ancona, 60126, Italy

  • Baptist Cancer Center - Memphis

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • CHA Bundang Medical Center

    RECRUITING

    Seongnam-si, 13496, South Korea

  • CHU UCL Namur

    RECRUITING

    Namur, 5000, Belgium

  • CIO Clara Campal

    RECRUITING

    Madrid, 28050, Spain

  • CTR Eugène Marquis

    NOT_YET_RECRUITING

    Rennes, 35042, France

  • CTR François Baclesse

    RECRUITING

    Caen, 14076, France

  • CTR Georges-François Leclerc

    NOT_YET_RECRUITING

    Dijon, 21000, France

  • CTR Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Centre Hospitalier Universitaire de Liège

    TERMINATED

    Liège, 4000, Belgium

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Clínica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, 28022, Spain

  • Community Health Network

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Complejo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Ellison Medical Institute

    NOT_YET_RECRUITING

    Los Angeles, California, 90064, United States

  • Evang. Kliniken Essen-Mitte gGmbh

    NOT_YET_RECRUITING

    Essen, 45136, Germany

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 200032, China

  • Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • H. Lee Moffitt Cancer Center and Research Institute

    RECRUITING

    Tampa, Florida, 33612, United States

  • HOP Tenon

    RECRUITING

    Paris, 75020, France

  • Hakuaikai Sagara Hospital

    RECRUITING

    Kagoshima, 892-0833, Japan

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, 150081, China

  • Helios CR Inc

    RECRUITING

    Lakeland, Florida, 33812, United States

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, 450003, China

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, 8906, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Virgen De La Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Humanitas Istituto Clinico Catanese S.p.A.

    RECRUITING

    Misterbianco (CT), 95045, Italy

  • Hôpital Vivalia De Libramont

    RECRUITING

    Libramont-Chevigny, 6800, Belgium

  • INS Bergonie

    RECRUITING

    Bordeaux, 33000, France

  • INS Claudius Regaud IUCT-Oncopole

    RECRUITING

    Toulouse, 31059, France

  • INS Paoli-Calmettes

    RECRUITING

    Marseille, 13273, France

  • Inova Schar Cancer Institute

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Institut de Cancérologie de Strasbourg

    RECRUITING

    Strasbourg, 67200, France

  • Institut de Cancérologie de l'Ouest

    RECRUITING

    Saint-Herblain, 44800, France

  • Instituto Valenciano de Oncología

    RECRUITING

    Valencia, 46009, Spain

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • Istituto Di Candiolo

    RECRUITING

    Candiolo (TO), 10060, Italy

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    RECRUITING

    Naples, 80131, Italy

  • Istituto Scientifico Romagnolo

    RECRUITING

    Meldola (FC), 47014, Italy

  • Japanese Foundation for Cancer Research

    RECRUITING

    Tokyo, Koto-ku, 135-8550, Japan

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, 210029, China

  • Jilin Province Cancer Hospital

    RECRUITING

    Changchun, 130012, China

  • Kanagawa Cancer Center

    RECRUITING

    Kanagawa, Yokohama, 241-8515, Japan

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 2841, South Korea

  • Kyoto University Hospital

    RECRUITING

    Kyoto, 606-8507, Japan

  • Memorial Sloan-Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa-shi, 277-8577, Japan

  • New York Cancer & Blood Specialists

    RECRUITING

    Shirley, New York, 11967, United States

  • Nottingham University Hospital

    NOT_YET_RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Orchard Healthcare Research Inc.- Skokie

    RECRUITING

    Skokie, Illinois, 60077, United States

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, 541-8567, Japan

  • Ospedale San Raffaele S.r.l.

    RECRUITING

    Milan, 20132, Italy

  • Penn State Milton S. Hershey Medical Center

    NOT_YET_RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Royal Free Hospital

    RECRUITING

    London, NW3 2QG, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 6591, South Korea

  • Sharp Memorial Hospital

    RECRUITING

    San Diego, California, 92123, United States

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

    RECRUITING

    Hangzhou, 310000, China

  • St Bartholomew's Hospital

    NOT_YET_RECRUITING

    London, EC1A 7BE, United Kingdom

  • St James's University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Tennessee Oncology, Pllc

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    RECRUITING

    Seoul, 6273, South Korea

  • The Christie Hospital

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, 130021, China

  • The Methodist Hospital Research Institute

    RECRUITING

    Houston, Texas, 77030, United States

  • The Oncology Institute of Hope and Innovation

    RECRUITING

    Cerritos, California, 90703, United States

  • The Royal Marsden Hospital, Chelsea

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden Hospital, Sutton

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Tianjin Cancer Hospital

    RECRUITING

    Tianjin, 300060, China

  • Tokai University Hospital

    RECRUITING

    Isehara, 259-1193, Japan

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

  • University College Hospital

    RECRUITING

    London, NW1 2BU, United Kingdom

  • University of California Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Universitätsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitätsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitätsklinikum Mannheim GmbH

    NOT_YET_RECRUITING

    Mannheim, 68167, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, 89075, Germany

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Velindre Cancer Centre

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Virginia Cancer Specialists, PC

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

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