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

May 22, 2026 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

768

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Not yet recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:
      • Edegem, Belgium, 2650
      • Leuven, Belgium, 3000
      • Libramont-Chevigny, Belgium, 6800
      • Liège, Belgium, 4000
        • Terminated
        • Centre Hospitalier Universitaire de Liège
      • Namur, Belgium, 5000
  • China
      • Changchun, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, China, 130012
        • Recruiting
        • Jilin Province Cancer Hospital
        • Contact:
      • Hangzhou, China, 310000
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Harbin, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
      • Nanjing, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:
      • Zhengzhou, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
  • France
      • Bordeaux, France, 33000
      • Caen, France, 14076
        • Not yet recruiting
        • CTR François Baclesse
        • Contact:
      • Dijon, France, 21000
        • Not yet recruiting
        • CTR Georges-François Leclerc
        • Contact:
      • Lyon, France, 69008
      • Marseille, France, 13273
        • Not yet recruiting
        • INS Paoli-Calmettes
        • Contact:
      • Paris, France, 75020
      • Rennes, France, 35042
        • Not yet recruiting
        • CTR Eugène Marquis
        • Contact:
      • Saint-Herblain, France, 44800
        • Not yet recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
      • Strasbourg, France, 67200
        • Not yet recruiting
        • Institut de Cancerologie de Strasbourg
        • Contact:
      • Toulouse, France, 31059
        • Not yet recruiting
        • INS Claudius Regaud IUCT-Oncopole
        • Contact:
      • Villejuif, France, 94805
        • Not yet recruiting
        • Institut Gustave Roussy
        • Contact:
  • Germany
      • Dresden, Germany, 01307
        • Not yet recruiting
        • Universitätsklinikum Carl Gustav Carus Dresden
        • Contact:
      • Erlangen, Germany, 91054
      • Essen, Germany, 45136
      • Hamburg, Germany, 22763
      • Mannheim, Germany, 68167
        • Not yet recruiting
        • Universitätsklinikum Mannheim GmbH
        • Contact:
      • Ulm, Germany, 89075
  • Italy
      • Candiolo (TO), Italy, 10060
        • Not yet recruiting
        • Istituto Di Candiolo
        • Contact:
      • Foggia, Italy, 71122
        • Not yet recruiting
        • Az.Osp. Universitaria "Ospedali Riuniti"
        • Contact:
      • Meldola (FC), Italy, 47014
        • Not yet recruiting
        • Istituto Scientifico Romagnolo
        • Contact:
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
        • Contact:
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l.
        • Contact:
      • Misterbianco (CT), Italy, 95045
        • Not yet recruiting
        • Humanitas Istituto Clinico Catanese S.p.A.
        • Contact:
      • Naples, Italy, 80131
        • Not yet recruiting
        • Istituto Nazionale IRCCS Tumori Fondazione Pascale
        • Contact:
      • Rozzano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 464-8681
        • Not yet recruiting
        • Aichi Cancer Center Hospital
        • Contact:
      • Isehara, Japan, 259-1193
        • Not yet recruiting
        • Tokai University Hospital
        • Contact:
      • Kagoshima, Japan, 892-0833
        • Recruiting
        • Hakuaikai Sagara Hospital
        • Contact:
      • Kanagawa, Yokohama, Japan, 241-8515
      • Kashiwa-shi, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
        • Contact:
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
        • Contact:
      • Tokyo, Koto-ku, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research
        • Contact:
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seongnam-si, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
      • Seoul, South Korea, 3080
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 6273
        • Not yet recruiting
        • The Catholic University of Korea, Seoul St.Mary's Hospital
        • Contact:
      • Seoul, South Korea, 2841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
      • Seoul, South Korea, 6591
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
  • Spain
      • A Coruña, Spain, 15006
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 8906
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Fundación Jiménez Díaz
        • Contact:
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
      • Madrid, Spain, 28050
      • Madrid, Spain, 28022
        • Recruiting
        • Clinica Universidad de Navarra - Madrid
        • Contact:
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen De La Macarena
        • Contact:
      • Valencia, Spain, 46009
        • Not yet recruiting
        • Instituto Valenciano de Oncologia
        • Contact:
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
      • Leeds, United Kingdom, LS9 7TF
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, EC1A 7BE
      • London, United Kingdom, NW1 2BU
      • London, United Kingdom, SW3 6JJ
      • Manchester, United Kingdom, M20 4BX
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
      • Nottingham, United Kingdom, NG5 1PB
      • Sutton, United Kingdom, SM2 5PT
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • California
      • Cerritos, California, United States, 90703
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90067
      • Los Angeles, California, United States, 90064
      • Orange, California, United States, 92868
      • San Diego, California, United States, 92123
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Florida
      • Jacksonville, Florida, United States, 32224
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • H. Lee Moffitt Cancer Center and Research Institute
        • Contact:
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Not yet recruiting
        • Orchard Healthcare Research Inc.- Skokie
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46250
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New York
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Contact:
      • Shirley, New York, United States, 11967
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Not yet recruiting
        • Penn State Milton S. Hershey Medical Center
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
    • Tennessee
      • Memphis, Tennessee, United States, 38120
      • Nashville, Tennessee, United States, 37203
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • The Methodist Hospital Research Institute
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
      • Fairfax, Virginia, United States, 22031
    • Washington
      • Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine
Dose escalation (Phase Ib)
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab emtansine
Trastuzumab emtansine
Other Names:
  • T-DM1; Kadcyla®
Experimental: Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan
Dose escalation (Phase Ib)
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan
Other Names:
  • T-DXd; Enhertu®
Experimental: Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan
Dose escalation (Phase Ib)
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan
Other Names:
  • T-DXd; Enhertu®
Experimental: Phase II - Cohort D: zongertinib + Trastuzumab emtansine
Dose optimization (Phase II).
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab emtansine
Trastuzumab emtansine
Other Names:
  • T-DM1; Kadcyla®
Experimental: Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan
Dose optimization (Phase II).
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan
Other Names:
  • T-DXd; Enhertu®
Experimental: Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan
Dose optimization (Phase II).
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan
Other Names:
  • T-DXd; Enhertu®
Experimental: Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine
Dose escalation (Phase Ib)
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab
Herceptin®
Drug: Capecitabine
Xeloda®
Experimental: Phase Ib - Cohort K: zongertinib + trastuzumab
Dose escalation (Phase Ib)
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab
Herceptin®
Experimental: Phase II - Cohort H: zongertinib + trastuzumab + capecitabine
Dose optimization (Phase II).
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab
Herceptin®
Drug: Capecitabine
Xeloda®
Experimental: Phase II - Cohort I: zongertinib
Dose optimization (Phase II).
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Experimental: Phase II - Cohort J: zongertinib + trastuzumab
Dose optimization (Phase II).
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab
Herceptin®
Experimental: Phase II - Cohort I-ext: zongertinib
Extension Phase II
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Experimental: Phase II - Cohort J-ext: zongertinib + trastuzumab
Extension Phase II
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab
Herceptin®
Experimental: Phase Ib - Cohort M: zongertinib + mFOLFOX6
Dose escalation (Phase Ib)
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: mFOLFOX6
mFOLFOX6
Experimental: Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6
Dose escalation (Phase Ib)
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab
Herceptin®
Drug: mFOLFOX6
mFOLFOX6
Experimental: Phase Ib - Cohort O: zongertinib + zanidatamab
Dose escalation (Phase Ib) - is not conducted in China or South Korea
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: zanidatamab
zanidatamab
Experimental: Phase II - Cohort L: zongertinib + trastuzumab
Dose justification (Phase II)
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab
Herceptin®
Experimental: Phase II - Cohort L-ext: zongertinib + trastuzumab
Extension Phase II
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®
Drug: Trastuzumab
Herceptin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time Frame: up to 21 days
The MTD evaluation period is defined as the first 21 days of the first treatment cycle for Cohorts A, B, C, G, K, and O. The MTD evaluation period is defined as the first 28 days after the first administration of any trial medication for Cohorts M and N.
up to 21 days
Dose optimization and justification (Phase II): Objective response (OR)
Time Frame: up to 50 months
Objective response (OR) is defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review.
up to 50 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose escalation (Phase Ib): Objective response (OR)
Time Frame: up to 50 months
up to 50 months
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) during the entire treatment period
Time Frame: up to 50 months
up to 50 months
Dose escalation (Phase Ib): Maximum measured concentration of zongertinib (at steady state) (Cmax,(ss))
Time Frame: up to 2 days
For cycle 2 only.
up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to 4h at steady state (AUC0-4h,ss)
Time Frame: up to 2 days
For cycle 2 only.
up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss)
Time Frame: up to 2 days
For cycle 2 only.
up to 2 days
Dose optimization and justification (Phase II): Progression-free survival (PFS)
Time Frame: up to 50 months
PFS is defined as the time from treatment start until the earliest date of tumor progression according RECIST 1.1 based on investigator review or death from any cause, whichever occurs first.
up to 50 months
Dose optimization and justification (Phase II): Disease control (DC)
Time Frame: up to 50 months
DC is defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by investigator review.
up to 50 months
Dose optimization and justification (Phase II): Occurrence of treatment-emergent AEs leading to zongertinib (BI 1810631) dose reduction during the on-treatment period
Time Frame: up to 50 months
up to 50 months
Dose optimization and justification (Phase II): Maximum measured concentration (at steady state) (Cmax,(ss))
Time Frame: up to 50 months
up to 50 months
Dose optimization and justification (Phase II): Area under the concentration-time curve over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss)
Time Frame: up to 50 months
up to 50 months
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE
Time Frame: up to 24 weeks

The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item library was developed to elicit symptomatic toxicity information directly from patients in cancer clinical trials. The items selected for this trial are: Mouth/throat sores, Taste changes, Decreased appetite, Nausea, Vomiting, Constipation, Diarrhoea, Shortness of breath, Cough, Rash, Skin dryness, Hair loss, Itching, Numbness & Tingling, Fatigue, Nosebleed, Headache.

PRO-CTCAE responses are scored from 0 (=none) to 4 (=very severe) (or 0/1 for absent/present).
up to 24 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL46
Time Frame: up to 48 weeks
The EORTC IL46 is a single question that assesses bother (burden) of treatment. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
up to 48 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL19
Time Frame: up to 48 weeks
The EORTC IL19 consists of five physical functioning scale items. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

January 8, 2029

Study Completion (Estimated)

January 8, 2029

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1479-0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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Clinical Trials on Colorectal Cancer

  • University of California, San Francisco
    Completed
    Diet Education Program for Stage I-IV Colorectal Cancer Survivors
    Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditions
    United States
  • Fred Hutchinson Cancer Center
    National Cancer Institute (NCI)
    Terminated
    Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
    Rectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditions
    United States
  • University of Southern California
    National Cancer Institute (NCI)
    Active, not recruiting
    Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer
    Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditions
    United States
  • M.D. Anderson Cancer Center
    Recruiting
    Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
    Colorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditions
    United States
  • Sidney Kimmel Comprehensive Cancer Center at Thomas...
    United States Department of Defense
    Active, not recruiting
    Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
    Colorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditions
    United States
  • M.D. Anderson Cancer Center
    National Cancer Institute (NCI)
    Active, not recruiting
    Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer
    Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditions
    United States
  • Wake Forest University Health Sciences
    National Cancer Institute (NCI)
    Completed
    Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors
    Cancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditions
    United States
  • University of Roma La Sapienza
    Completed
    Matrilysin Expression in Different Stages of Colorectal Tumors (MMP7)
    Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage I
    Italy
  • Emory University
    Bristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...
    Completed
    Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer
    Colorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal Cancer
    United States
  • University of Southern California
    National Cancer Institute (NCI); Amgen
    Terminated
    5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab
    Stage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...
    United States

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