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
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests zongertinib alone and with other cancer treatments to find doses people can tolerate and see if tumors shrink. It is for adults with HER2+ cancer that has spread, cannot be removed by surgery, and has not responded to past treatment. HER2 is a protein that helps cancer cells grow.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18, or the legal age to consent if it is higher in your country.
- Have HER2+ cancer that has spread: breast, stomach, esophagus (food pipe), the area where the stomach and esophagus meet, or colon or rectum cancer.
- For breast, stomach, or esophagus cancer, the cancer must have worsened after HER2 treatment. Some groups require past treatment with trastuzumab deruxtecan (T-DXd).
- For colon or rectum cancer, have had at least one treatment for advanced cancer, with cancer that worsened or returned. Your doctor must think further standard treatment is unlikely to help or be tolerable.
- For Part 2, provide a stored tumor sample, if possible from an area not treated with radiation before the sample was taken.
- Have at least one tumor that can be measured on scans.
- Be fully active or able to do light work, and have organs working well enough based on blood tests.
- Other entry rules also apply.
Who can't join
- Certain past HER2 drugs or capecitabine may prevent you from joining some groups. The rules and limited exceptions depend on the group.
- Cancer in the brain that is not controlled or causes symptoms, or cancer in the tissue covering the brain and spinal cord.
- A heart test showing a longer-than-allowed delay between heartbeats, called a QTcF interval over 470 milliseconds.
- Conditions that raise the risk of dangerous heart rhythms, such as heart failure, low potassium, or certain personal or family heart histories.
- Heart pumping strength below 50% or below the study site's normal range, measured within 28 days before group assignment.
- Past lung inflammation not caused by infection that needed steroids, current lung inflammation, or possible lung inflammation that scans cannot rule out.
- Other exclusion rules also apply.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (26)
CA
- The Oncology Institute of Hope and Innovation · Cerritos, CA 90703Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Cerritos
- Ellison Medical Institute · Los Angeles, CA 90064Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Los Angeles
- Valkyrie Clinical Trials · Los Angeles, CA 90067Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Los Angeles
- University of California Los Angeles · Los Angeles, CA 90095Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Los Angeles
- University of California Irvine · Orange, CA 92868Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Orange
- Sharp Memorial Hospital · San Diego, CA 92123Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in San Diego
CT
- Yale University School of Medicine · New Haven, CT 06510Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in New Haven
FL
- Helios CR Inc · Lakeland, FL 33812Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Lakeland
- H. Lee Moffitt Cancer Center and Research Institute · Tampa, FL 33612Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Tampa
IA
- University of Iowa Hospitals and Clinics · Iowa City, IA 52242Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Iowa City
IL
- Orchard Healthcare Research Inc.- Skokie · Skokie, IL 60077Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Skokie
IN
- Community Health Network · Indianapolis, IN 46250Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Indianapolis
MA
- Dana-Farber Cancer Institute · Boston, MA 02215Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Boston
MI
- University of Michigan · Ann Arbor, MI 48109Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Ann Arbor
NY
- Memorial Sloan-Kettering Cancer Center · New York, NY 10065Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in New York
- New York Cancer & Blood Specialists · Shirley, NY 11967Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Shirley
PA
- Penn State Milton S. Hershey Medical Center · Hershey, PA 17033Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Hershey
SD
- Avera Cancer Institute · Sioux Falls, SD 57105Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Sioux Falls
TN
- Baptist Cancer Center - Memphis · Memphis, TN 38120Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Memphis
- SCRI Oncology Partners · Nashville, TN 37203Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Nashville
- Tennessee Oncology, Pllc · Nashville, TN 37203Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Nashville
TX
- The Methodist Hospital Research Institute · Houston, TX 77030Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Houston
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Houston
VA
- Inova Schar Cancer Institute · Fairfax, VA 22031Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Fairfax
- Virginia Cancer Specialists, PC · Fairfax, VA 22031Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Fairfax
WA
- Fred Hutchinson Cancer Research Center · Seattle, WA 98109Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Seattle