Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers.
Sara Hurvitz, Matteo Simonelli, Ramón Yarza...
https://pubmed.ncbi.nlm.nih.gov/41108088Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID06324357
Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization Trial of Oral Zongertinib Alone or Combined With Other Agents for Advanced HER2+ Metastatic Breast, Gastric, Gastroesophageal Junction, Esophageal Adenocarcinoma, or Colorectal Cancer
Led by Boehringer Ingelheim · Updated on 2026-05-26
768
Participants Needed
108
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of zongertinib, alone and in combination with other treatments, for adults aged 18 years and older with various types of HER2-positive cancers that have spread and cannot be removed by surgery. This study aims to find a suitable dose of zongertinib that patients can tolerate when taken with therapies like trastuzumab deruxtecan, trastuzumab emtansine, trastuzumab with capecitabine, zanidatamab, or mFOLFOX6. The trial investigates whether zongertinib alone or combined with these treatments can shrink tumors and improve outcomes in advanced HER2-positive cancers. Participants receive treatment in cycles across two study parts. Part 1 involves increasing doses of zongertinib given to different groups to find the tolerated dose. Part 2 randomly assigns participants to groups receiving different zongertinib doses, either alone or combined with other drugs such as trastuzumab deruxtecan, trastuzumab emtansine, and others. Some groups enter extension phases to continue treatment based on prior dosing. The study uses an open-label design with multiple treatment cohorts. During the study, participants visit regularly for health checks, tumor imaging with CT or MRI, and monitoring for side effects or dose-limiting toxicities. Researchers assess tumor response and safety outcomes throughout treatment, including objective response and progression-free survival over up to 50 months. Patient-reported outcomes and laboratory tests support safety and efficacy evaluations. The study tracks adherence and health status to find the highest tolerated dose and assess whether zongertinib combinations help control the cancer.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older or over the legal age of consent in their country at the time of informed consent
- Documented HER2 overexpressing or amplified metastatic breast cancer, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma for cohorts A to K and O
- Documented HER2 overexpression/amplification for metastatic colorectal cancer for cohorts L (L-ext), M, and N
- Provide tumor tissue from non-radiated locations for Phase II dose optimization and justification, if possible
- History of prior treatment lines in palliative setting with documented progression after HER2-directed treatment for most cohorts
- 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
You will not qualify if you...
- Previous treatment with any small molecule HER2 inhibitor in palliative setting for specific cohorts (D, E, F, H, L, L-ext, M, N), with limited exceptions
- Previous treatment with trastuzumab deruxtecan (T-DXd) in cohorts E and F, limited to 15 patients per dose level
- Previous treatment with trastuzumab emtansine (T-DM1) in cohorts D and H, limited to 15 patients per dose level
- Previous treatment with capecitabine in cohorts D and H, limited to 15 patients per dose level
- Presence of uncontrolled or symptomatic brain metastases or leptomeningeal disease
- Mean resting corrected QT interval (QTcF) greater than 470 msec
- Conditions increasing risk of QT interval prolongation or arrhythmic events such as heart failure, hypokalemia, long QT syndrome, or family history of sudden death under 40 years
- Ejection fraction less than 50% or lower limit of normal within 28 days before randomization
- History of non-infectious interstitial lung disease or pneumonitis requiring steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis not ruled out by imaging at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 50 months
Participants receive oral Zongertinib alone or in combination with other drugs such as trastuzumab emtansine, trastuzumab deruxtecan, trastuzumab, capecitabine, mFOLFOX6, or zanidatamab as part of dose escalation and dose optimization phases.
Visits occur regularly during treatment cycles as per assigned cohort
Trial Site Locations
Total: 108 locations
1
Mayo Clinic-Arizona
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
The Oncology Institute of Hope and Innovation
Cerritos, California, United States, 90703
Actively Recruiting
3
Ellison Medical Institute
Los Angeles, California, United States, 90064
Not Yet Recruiting
4
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
5
University of California Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
6
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
7
Sharp Memorial Hospital
San Diego, California, United States, 92123
Not Yet Recruiting
8
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
Mayo Clinic - Florida
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
10
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Not Yet Recruiting
11
Orchard Healthcare Research Inc.- Skokie
Skokie, Illinois, United States, 60077
Not Yet Recruiting
12
Community Health Network
Indianapolis, Indiana, United States, 46250
Not Yet Recruiting
13
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
14
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
15
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
16
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
17
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
18
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
19
New York Cancer & Blood Specialists
Shirley, New York, United States, 11967
Not Yet Recruiting
20
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Not Yet Recruiting
21
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Not Yet Recruiting
22
Baptist Cancer Center - Memphis
Memphis, Tennessee, United States, 38120
Not Yet Recruiting
23
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
24
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Actively Recruiting
25
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Not Yet Recruiting
26
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
27
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Not Yet Recruiting
28
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
29
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
30
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Not Yet Recruiting
31
Edegem - UNIV UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
32
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
33
Hôpital Vivalia De Libramont
Libramont-Chevigny, Belgium, 6800
Actively Recruiting
34
Centre Hospitalier Universitaire de Liège
Liège, Belgium, 4000
Terminated
35
CHU UCL Namur
Namur, Belgium, 5000
Actively Recruiting
36
Jilin Province Cancer Hospital
Changchun, China, 130012
Actively Recruiting
37
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
38
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, China, 310000
Actively Recruiting
39
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Actively Recruiting
40
Jiangsu Province Hospital
Nanjing, China, 210029
Actively Recruiting
41
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
42
Tianjin Cancer Hospital
Tianjin, China, 300060
Actively Recruiting
43
Henan Cancer Hospital
Zhengzhou, China, 450003
Actively Recruiting
44
INS Bergonie
Bordeaux, France, 33000
Not Yet Recruiting
45
CTR François Baclesse
Caen, France, 14076
Not Yet Recruiting
46
CTR Georges-François Leclerc
Dijon, France, 21000
Not Yet Recruiting
47
CTR Leon Berard
Lyon, France, 69008
Not Yet Recruiting
48
INS Paoli-Calmettes
Marseille, France, 13273
Not Yet Recruiting
49
HOP Tenon
Paris, France, 75020
Not Yet Recruiting
50
CTR Eugène Marquis
Rennes, France, 35042
Not Yet Recruiting
51
Institut de Cancérologie de l'Ouest
Saint-Herblain, France, 44800
Not Yet Recruiting
52
Institut de Cancérologie de Strasbourg
Strasbourg, France, 67200
Not Yet Recruiting
53
INS Claudius Regaud IUCT-Oncopole
Toulouse, France, 31059
Not Yet Recruiting
54
Institut Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
55
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Not Yet Recruiting
56
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Not Yet Recruiting
57
Evang. Kliniken Essen-Mitte gGmbh
Essen, Germany, 45136
Not Yet Recruiting
58
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, Germany, 22763
Not Yet Recruiting
59
Universitätsklinikum Mannheim GmbH
Mannheim, Germany, 68167
Not Yet Recruiting
60
Universitätsklinikum Ulm
Ulm, Germany, 89075
Not Yet Recruiting
61
Istituto Di Candiolo
Candiolo (TO), Italy, 10060
Not Yet Recruiting
62
Az.Osp. Universitaria "Ospedali Riuniti"
Foggia, Italy, 71122
Not Yet Recruiting
63
Istituto Scientifico Romagnolo
Meldola (FC), Italy, 47014
Not Yet Recruiting
64
Ospedale San Raffaele S.r.l.
Milan, Italy, 20132
Actively Recruiting
65
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
66
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco (CT), Italy, 95045
Not Yet Recruiting
67
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, Italy, 80131
Not Yet Recruiting
68
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
69
Aichi Cancer Center Hospital
Aichi, Nagoya, Japan, 464-8681
Not Yet Recruiting
70
Tokai University Hospital
Isehara, Japan, 259-1193
Not Yet Recruiting
71
Hakuaikai Sagara Hospital
Kagoshima, Japan, 892-0833
Actively Recruiting
72
Kanagawa Cancer Center
Kanagawa, Yokohama, Japan, 241-8515
Actively Recruiting
73
National Cancer Center Hospital East
Kashiwa-shi, Japan, 277-8577
Actively Recruiting
74
Kyoto University Hospital
Kyoto, Japan, 606-8507
Actively Recruiting
75
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Actively Recruiting
76
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan, 135-8550
Actively Recruiting
77
CHA Bundang Medical Center
Seongnam-si, South Korea, 13496
Actively Recruiting
78
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
79
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
80
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
81
Korea University Anam Hospital
Seoul, South Korea, 2841
Actively Recruiting
82
Seoul National University Hospital
Seoul, South Korea, 3080
Not Yet Recruiting
83
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, South Korea, 6273
Not Yet Recruiting
84
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 6591
Actively Recruiting
85
Hospital Teresa Herrera
A Coruña, Spain, 15006
Actively Recruiting
86
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
87
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
88
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
89
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 8906
Actively Recruiting
90
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
91
Clínica Universidad de Navarra - Madrid
Madrid, Spain, 28022
Actively Recruiting
92
Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
93
Hospital Clínico San Carlos
Madrid, Spain, 28040
Not Yet Recruiting
94
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
95
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
96
CIO Clara Campal
Madrid, Spain, 28050
Actively Recruiting
97
Hospital Universitario Virgen De La Macarena
Seville, Spain, 41009
Actively Recruiting
98
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Not Yet Recruiting
99
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Not Yet Recruiting
100
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Not Yet Recruiting
101
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
102
University College Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
103
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
104
The Royal Marsden Hospital, Chelsea
London, United Kingdom, SW3 6JJ
Actively Recruiting
105
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
106
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Not Yet Recruiting
107
Nottingham University Hospital
Nottingham, United Kingdom, NG5 1PB
Not Yet Recruiting
108
The Royal Marsden Hospital, Sutton
Sutton, United Kingdom, SM2 5PT
Not Yet Recruiting
Loading map...
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
18
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here