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NCT06581432PHASE2Recruiting

Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations

Boehringer Ingelheim

Start Date

10/11/2024

Completion Date

12/29/2028

Summary

This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2. Participants are put into groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it. Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Zongertinib

Interested in This Trial?

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Conditions

Solid Tumours

Locations

Alaska Oncology and Hematology, LLC

Anchorage, Alaska 99508

United States

University of Arizona Comprehensive Cancer Center

Tucson, Arizona 85719

United States

Precision NextGen Oncology

Beverly Hills, California 90212

United States

Scripps Cancer Center Torrey Pines

La Jolla, California 92037

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

Yale University School of Medicine

New Haven, Connecticut 06511

United States

BRCR Global - Tamarac

Tamarac, Florida 33321

United States

Illinois Cancer Specialists

Arlington Heights, Illinois 60005

United States

Community MD Anderson Cancer Center - East Medical Oncology

Indianapolis, Indiana 46219

United States

Maryland Oncology Hematology, Columbia

Columbia, Maryland 21044

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Presbyterian Healthcare Services

Albuquerque, New Mexico 87110

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Memorial Sloan-Kettering Cancer Center

New York, New York 10065

United States

Taylor Cancer Research Center

Maumee, Ohio 43537

United States

Alliance Cancer Specialists, PC, Wynnewood

Wynnewood, Pennsylvania 19096

United States

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas 75230

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Texas Oncology - Plano West

Plano, Texas 75093

United States

Virginia Cancer Specialists, PC

Fairfax, Virginia 22031

United States

Macquarie University

Macquarie Park, New South Wales 2109

Australia

GenesisCare North Shore

St Leonards, New South Wales 2065

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Cancer Research South Australia

Adelaide, South Australia 5000

Australia

St John of God Subiaco Hospital

Subiaco, Western Australia 6008

Australia

Cliniques Universitaires Saint-Luc

Brussels, 1200

Belgium

Universitair Ziekenhuis Antwerpen

Edegem, 2650

Belgium

Cross Cancer Institute (University of Alberta)

Edmonton, Alberta T6G 1Z2

Canada

BC Cancer Agency - Vancouver

Vancouver, British Columbia V5Z 4E6

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec H2X 0A9

Canada

McGill University Health Centre (MUHC)

Montreal, Quebec H4A 3J1

Canada

Peking University First Hospital

Beijing, 100034

China

Hunan Province Tumor Hospital

Changsha, 410013

China

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

Hangzhou, 310016

China

Anhui Provincial Cancer Hospital

Hefei, 230001

China

The First Affiliated Hospital of Nanchang University

Nanchang, 330006

China

Nanjing Drum Tower Hospital

Nanjing, 210008

China

Shanghai East Hospital

Shanghai, 200120

China

Shanghai GoBroad Cancer Hospital

Shanghai, 200131

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430022

China

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

Wuhan, 430030

China

Henan Cancer Hospital

Zhengzhou, 450008

China

INS Bergonie

Bordeaux, 33000

France

CTR Georges-François Leclerc

Dijon, 21079

France

CTR Leon Berard

Lyon, 69373

France

HOP Timone

Marseille, 13385

France

HOP la Milétrie

Poitiers, 86000

France

Institut Gustave Roussy

Villejuif, 94805

France

Charité - Universitätsmedizin Berlin

Berlin, 12203

Germany

Justus-Liebig Universität Gießen

Giessen, 35392

Germany

Asklepios Kliniken GmbH & Co. KGaA

Hamburg, 22763

Germany

Universität Leipzig

Leipzig, 04103

Germany

Universitätsklinikum Mannheim GmbH

Mannheim, 68167

Germany

Klinikum rechts der Isar der Technischen Universität München

München, 81675

Germany

Az. Ospedaliere Umberto I di Ancona

Ancona, 60020

Italy

Centro di riferimento Oncologico

Aviano (PN), 33081

Italy

Istituto Scientifico Romagnolo

Meldola (FC), 47014

Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

AOU Università degli Studi della Campania Luigi Vanvitelli

Naples, 80131

Italy

Fondazione Policlinico Universitario Campus Bio-medico

Rome, 00128

Italy

Aichi Cancer Center Hospital

Aichi, Nagoya, 464-8681

Japan

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577

Japan

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582

Japan

Hokkaido University Hospital

Hokkaido, Sapporo, 060-8648

Japan

Okayama University Hospital

Okayama, Okayama, 700-8558

Japan

Osaka International Cancer Institute

Osaka, Osaka, 541-8567

Japan

Shizuoka Cancer Center

Shizuoka, Sunto-gun, 411-8777

Japan

National Cancer Center Hospital

Tokyo, Chuo-ku, 104-0045

Japan

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, 135-8550

Japan

Nederlands Kanker Instituut

Amsterdam, 1066 CX

Netherlands

Radboud Universitair Medisch Centrum

Nijmegen, 6525 GL

Netherlands

Oslo Universitetssykehus HF, Radiumhospitalet

Oslo, N-0379

Norway

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935

Puerto Rico

National Cancer Centre Singapore

Singapore, 168583

Singapore

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 135-710

South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006

Spain

Hospital Germans Trias i Pujol

Badalona, 08916

Spain

Hospital del Mar

Barcelona, 08003

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Duran i Reynals

Barcelona, 08908

Spain

Clínica Universidad de Navarra - Madrid

Madrid, 28027

Spain

Hospital Clínico San Carlos

Madrid, 28040

Spain

Clínica Universidad de Navarra

Pamplona, 31008

Spain

Hospital Virgen del Rocio

Seville, 41013

Spain

Hospital Clinico De Valencia (INCLIVA)

Valencia, 46010

Spain

Ninewells Hospital & Medical School

Dundee, DD1 9SY

United Kingdom

Hammersmith Hospital

London, W12 0HS

United Kingdom

The Christie Hospital

Manchester, M20 4BX

United Kingdom