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NCT06324357PHASE1, PHASE2Recruiting

Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread

Boehringer Ingelheim

Start Date

6/3/2024

Completion Date

1/8/2029

Summary

This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow. In this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group. During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Zongertinib

DRUG

Trastuzumab deruxtecan

DRUG

Trastuzumab emtansine

DRUG

Trastuzumab

DRUG

Capecitabine

DRUG

mFOLFOX6

DRUG

zanidatamab

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Conditions

Metastatic Breast CancerMetastatic Gastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaEsophageal AdenocarcinomaColorectal Cancer

Locations

The Oncology Institute of Hope and Innovation

Cerritos, California 90703

United States

Ellison Medical Institute

Los Angeles, California 90064

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

University of California Los Angeles

Los Angeles, California 90095

United States

University of California Irvine

Orange, California 92868

United States

Sharp Memorial Hospital

San Diego, California 92123

United States

Yale University School of Medicine

New Haven, Connecticut 06510

United States

Helios CR Inc

Lakeland, Florida 33812

United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida 33612

United States

Orchard Healthcare Research Inc.- Skokie

Skokie, Illinois 60077

United States

Community Health Network

Indianapolis, Indiana 46250

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Memorial Sloan-Kettering Cancer Center

New York, New York 10065

United States

New York Cancer & Blood Specialists

Shirley, New York 11967

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

Baptist Cancer Center - Memphis

Memphis, Tennessee 38120

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Tennessee Oncology, Pllc

Nashville, Tennessee 37203

United States

The Methodist Hospital Research Institute

Houston, Texas 77030

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Inova Schar Cancer Institute

Fairfax, Virginia 22031

United States

Virginia Cancer Specialists, PC

Fairfax, Virginia 22031

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109

United States

Cliniques Universitaires Saint-Luc

Brussels, 1200

Belgium

Universitair Ziekenhuis Antwerpen

Edegem, 2650

Belgium

UZ Leuven

Leuven, 3000

Belgium

Hôpital Vivalia De Libramont

Libramont-Chevigny, 6800

Belgium

Centre Hospitalier Universitaire de Liège

Liège, 4000

Belgium

CHU UCL Namur

Namur, 5000

Belgium

Jilin Province Cancer Hospital

Changchun, 130012

China

The First Hospital of Jilin University

Changchun, 130021

China

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

Hangzhou, 310000

China

Harbin Medical University Cancer Hospital

Harbin, 150081

China

Jiangsu Province Hospital

Nanjing, 210029

China

Fudan University Shanghai Cancer Center

Shanghai, 200032

China

Tianjin Cancer Hospital

Tianjin, 300060

China

Henan Cancer Hospital

Zhengzhou, 450003

China

INS Bergonie

Bordeaux, 33000

France

CTR François Baclesse

Caen, 14076

France

CTR Georges-François Leclerc

Dijon, 21000

France

CTR Leon Berard

Lyon, 69008

France

INS Paoli-Calmettes

Marseille, 13273

France

HOP Tenon

Paris, 75020

France

CTR Eugène Marquis

Rennes, 35042

France

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44800

France

Institut de Cancérologie de Strasbourg

Strasbourg, 67200

France

INS Claudius Regaud IUCT-Oncopole

Toulouse, 31059

France

Institut Gustave Roussy

Villejuif, 94805

France

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Universitätsklinikum Erlangen

Erlangen, 91054

Germany

Evang. Kliniken Essen-Mitte gGmbh

Essen, 45136

Germany

Asklepios Kliniken GmbH & Co. KGaA

Hamburg, 22763

Germany

Universitätsklinikum Mannheim GmbH

Mannheim, 68167

Germany

Universitätsklinikum Ulm

Ulm, 89075

Germany

Istituto Di Candiolo

Candiolo (TO), 10060

Italy

Az.Osp. Universitaria "Ospedali Riuniti"

Foggia, 71122

Italy

Istituto Scientifico Romagnolo

Meldola (FC), 47014

Italy

Ospedale San Raffaele S.r.l.

Milan, 20132

Italy

Istituto Europeo di Oncologia

Milan, 20141

Italy

Humanitas Istituto Clinico Catanese S.p.A.

Misterbianco (CT), 95045

Italy

Istituto Nazionale IRCCS Tumori Fondazione Pascale

Naples, 80131

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Aichi Cancer Center Hospital

Aichi, Nagoya, 464-8681

Japan

Tokai University Hospital

Isehara, 259-1193

Japan

Hakuaikai Sagara Hospital

Kagoshima, 892-0833

Japan

Kanagawa Cancer Center

Kanagawa, Yokohama, 241-8515

Japan

National Cancer Center Hospital East

Kashiwa-shi, 277-8577

Japan

Kyoto University Hospital

Kyoto, 606-8507

Japan

Osaka International Cancer Institute

Osaka, 541-8567

Japan

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, 135-8550

Japan

CHA Bundang Medical Center

Seongnam-si, 13496

South Korea

Seoul National University Bundang Hospital

Seongnam-si, 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Korea University Anam Hospital

Seoul, 2841

South Korea

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

Seoul, 6273

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 6591

South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006

Spain

Hospital del Mar

Barcelona, 08003

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clínic de Barcelona

Barcelona, 08036

Spain

Hospital Duran i Reynals

L'Hospitalet de Llobregat, 8906

Spain

Hospital General Universitario Gregorio Marañón

Madrid, 28007

Spain

Clínica Universidad de Navarra - Madrid

Madrid, 28022

Spain

Fundación Jiménez Díaz

Madrid, 28040

Spain

Hospital Clínico San Carlos

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

CIO Clara Campal

Madrid, 28050

Spain

Hospital Universitario Virgen De La Macarena

Seville, 41009

Spain

Instituto Valenciano de Oncología

Valencia, 46009

Spain

Velindre Cancer Centre

Cardiff, CF14 2TL

United Kingdom

St James's University Hospital

Leeds, LS9 7TF

United Kingdom

St Bartholomew's Hospital

London, EC1A 7BE

United Kingdom

University College Hospital

London, NW1 2BU

United Kingdom

Royal Free Hospital

London, NW3 2QG

United Kingdom

The Royal Marsden Hospital, Chelsea

London, SW3 6JJ

United Kingdom

The Christie Hospital

Manchester, M20 4BX

United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom

Nottingham University Hospital

Nottingham, NG5 1PB

United Kingdom

The Royal Marsden Hospital, Sutton

Sutton, SM2 5PT

United Kingdom