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
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period — 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.
Dose optimization and justification (Phase II): Objective response (OR) — 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.
Trial sites (105)
Facility
City
Region
Status
The Oncology Institute of Hope and Innovation
Cerritos
California
Recruiting
Ellison Medical Institute
Los Angeles
California
Not Yet Recruiting
Valkyrie Clinical Trials
Los Angeles
California
Recruiting
University of California Los Angeles
Los Angeles
California
Recruiting
University of California Irvine
Orange
California
Recruiting
Sharp Memorial Hospital
San Diego
California
Recruiting
Yale University School of Medicine
New Haven
Connecticut
Recruiting
Helios CR Inc
Lakeland
Florida
Recruiting
H. Lee Moffitt Cancer Center and Research Institute
Tampa
Florida
Recruiting
Orchard Healthcare Research Inc.- Skokie
Skokie
Illinois
Recruiting
Community Health Network
Indianapolis
Indiana
Recruiting
University of Iowa Hospitals and Clinics
Iowa City
Iowa
Recruiting
Dana-Farber Cancer Institute
Boston
Massachusetts
Recruiting
University of Michigan
Ann Arbor
Michigan
Not Yet Recruiting
Memorial Sloan-Kettering Cancer Center
New York
New York
Recruiting
New York Cancer & Blood Specialists
Shirley
New York
Recruiting
Penn State Milton S. Hershey Medical Center
Hershey
Pennsylvania
Not Yet Recruiting
Avera Cancer Institute
Sioux Falls
South Dakota
Recruiting
Baptist Cancer Center - Memphis
Memphis
Tennessee
Recruiting
SCRI Oncology Partners
Nashville
Tennessee
Recruiting
Tennessee Oncology, Pllc
Nashville
Tennessee
Recruiting
The Methodist Hospital Research Institute
Houston
Texas
Recruiting
The University of Texas MD Anderson Cancer Center
Houston
Texas
Not Yet Recruiting
Inova Schar Cancer Institute
Fairfax
Virginia
Recruiting
Virginia Cancer Specialists, PC
Fairfax
Virginia
Recruiting
Fred Hutchinson Cancer Research Center
Seattle
Washington
Recruiting
Cliniques Universitaires Saint-Luc
Brussels
Belgium
Recruiting
Universitair Ziekenhuis Antwerpen
Edegem
Belgium
Recruiting
UZ Leuven
Leuven
Belgium
Recruiting
Hôpital Vivalia De Libramont
Libramont-Chevigny
Belgium
Recruiting
Centre Hospitalier Universitaire de Liège
Liège
Belgium
Terminated
CHU UCL Namur
Namur
Belgium
Recruiting
Jilin Province Cancer Hospital
Changchun
China
Recruiting
The First Hospital of Jilin University
Changchun
China
Recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou
China
Recruiting
Harbin Medical University Cancer Hospital
Harbin
China
Recruiting
Jiangsu Province Hospital
Nanjing
China
Recruiting
Fudan University Shanghai Cancer Center
Shanghai
China
Recruiting
Tianjin Cancer Hospital
Tianjin
China
Recruiting
Henan Cancer Hospital
Zhengzhou
China
Recruiting
+ 65 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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