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RECRUITING

NCT06324357

PHASE1/PHASE2

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

768

Start Date

2024-06-03

Completion Date

2029-01-08

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Metastatic Breast Cancer Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Esophageal Adenocarcinoma Colorectal Cancer

Interventions

DRUG

Zongertinib

DRUG

Trastuzumab deruxtecan

DRUG

Trastuzumab emtansine

DRUG

Trastuzumab

Herceptin®

DRUG

Capecitabine

Xeloda®

DRUG

mFOLFOX6

DRUG

zanidatamab

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.

Locations (107)

Mayo Clinic-Arizona

Phoenix, Arizona, United States

The Oncology Institute of Hope and Innovation

Cerritos, California, United States

Ellison Medical Institute

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Mayo Clinic - Florida

Jacksonville, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Orchard Healthcare Research Inc.- Skokie

Skokie, Illinois, United States

Community Health Network

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Baptist Cancer Center - Memphis

Memphis, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology, Pllc

Nashville, Tennessee, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Edegem - UNIV UZ Antwerpen

Edegem, Belgium

UZ Leuven

Leuven, Belgium

Hôpital Vivalia De Libramont

Libramont-Chevigny, Belgium

Centre Hospitalier Universitaire de Liège

Liège, Belgium

CHU UCL Namur

Namur, Belgium

Jilin Province Cancer Hospital

Changchun, China

The First Hospital of Jilin University

Changchun, China

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

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Jiangsu Province Hospital

Nanjing, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tianjin Cancer Hospital

Tianjin, China

Henan Cancer Hospital

Zhengzhou, China

INS Bergonie

Bordeaux, France

CTR François Baclesse

Caen, France

CTR Georges-François Leclerc

Dijon, France

CTR Leon Berard

Lyon, France

INS Paoli-Calmettes

Marseille, France

HOP Tenon

Paris, France

CTR Eugène Marquis

Rennes, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Institut de Cancérologie de Strasbourg

Strasbourg, France

INS Claudius Regaud IUCT-Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Evang. Kliniken Essen-Mitte gGmbh

Essen, Germany

Asklepios Kliniken GmbH & Co. KGaA

Hamburg, Germany

Universitätsklinikum Mannheim GmbH

Mannheim, Germany

Universitätsklinikum Ulm

Ulm, Germany

Istituto Di Candiolo

Candiolo (TO), Italy

Az.Osp. Universitaria "Ospedali Riuniti"

Foggia, Italy

Istituto Scientifico Romagnolo

Meldola (FC), Italy

Ospedale San Raffaele S.r.l.

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Humanitas Istituto Clinico Catanese S.p.A.

Misterbianco (CT), Italy

Istituto Nazionale IRCCS Tumori Fondazione Pascale

Naples, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Aichi Cancer Center Hospital

Aichi, Nagoya, Japan

Tokai University Hospital

Isehara, Japan

Hakuaikai Sagara Hospital

Kagoshima, Japan

Kanagawa Cancer Center

Kanagawa, Yokohama, Japan

National Cancer Center Hospital East

Kashiwa-shi, Japan

Kyoto University Hospital

Kyoto, Japan

Osaka International Cancer Institute

Osaka, Japan

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, Japan

CHA Bundang Medical Center

Seongnam-si, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

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

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital Teresa Herrera

A Coruña, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Duran i Reynals

L'Hospitalet de Llobregat, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Clínica Universidad de Navarra - Madrid

Madrid, Spain

Fundación Jiménez Díaz

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

CIO Clara Campal

Madrid, Spain

Hospital Universitario Virgen De La Macarena

Seville, Spain

Instituto Valenciano de Oncología

Valencia, Spain

Velindre Cancer Centre

Cardiff, United Kingdom

St James's University Hospital

Leeds, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

University College Hospital

London, United Kingdom

Royal Free Hospital

London, United Kingdom

The Royal Marsden Hospital, Chelsea

London, United Kingdom

The Christie

Manchester, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

The Royal Marsden Hospital, Sutton

Sutton, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (107)