Trial Title:
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
NCT ID:
NCT06324357
Condition:
Metastatic Breast Cancer
Metastatic Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
Conditions: Official terms:
Breast Neoplasms
Adenocarcinoma
Esophageal Neoplasms
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine
Trastuzumab deruxtecan
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zongertinib
Description:
Zongertinib
Arm group label:
Phase II - Cohort D: zongertinib + Trastuzumab emtansine
Arm group label:
Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan
Arm group label:
Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan
Arm group label:
Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine
Arm group label:
Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan
Arm group label:
Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan
Other name:
BI 1810631
Intervention type:
Drug
Intervention name:
Trastuzumab deruxtecan
Description:
Trastuzumab deruxtecan
Arm group label:
Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan
Arm group label:
Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan
Arm group label:
Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan
Arm group label:
Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan
Other name:
T-DXd; Enhertu®
Intervention type:
Drug
Intervention name:
Trastuzumab emtansine
Description:
Trastuzumab emtansine
Arm group label:
Phase II - Cohort D: zongertinib + Trastuzumab emtansine
Arm group label:
Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine
Other name:
T-DM1; Kadcyla®
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) or with trastuzumab emtansine (T-DM1). Another
purpose is to check whether zongertinib in combination with T-DXd or with T-DM1 can make
tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.
The study is split into treatment cycles. All study participants are treated with
zongertinib in combination with T-DXd or with T-DM1. This study has 2 parts. In Part 1,
participants 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 T-DXd or with T-DM1. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed and dated written Informed consent form (ICF) in accordance with
International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local
legislation prior to admission to the trial.
- 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 ICF.
- 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).
- For dose optimization (Phase II): Patient must provide tumor tissue from locations
not radiated prior to biopsy, if possible, collected through archival tissue.
- Documented investigator assessed progression.
- Recovered from any previous therapy-related toxicity to ≤ Common Terminology
Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for
alopecia, stable sensory neuropathy, and hypothyroidism (patients on thyroid
replacement therapy) which must be ≤ CTCAE Grade 2).
- Presence of at least one measurable lesion according to Response evaluation criteria
in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology
assessment.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. Further inclusion
criteria apply.
Exclusion Criteria:
- Previous or concomitant malignancies other than the one treated in this trial within
the previous 2 years, which require current systemic therapy except:
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local
treatment
- History or presence of cardiovascular abnormalities such as uncontrolled
hypertension, congestive heart failure New York Heart Association (NYHA)
classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which
are considered as clinically relevant by the investigator. Myocardial infarction (or
troponin levels consistent with myocardial infarction within 28 days of
randomization), stroke, or pulmonary embolism within 6 months prior to
randomization.
- Any clinically important abnormalities (as assessed by the investigator) in rhythm,
conduction, or morphology of resting electrocardiograms, e.g. complete left bundle
branch block, third degree heart block.
- 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, family history of long QT syndrome or unexplained
sudden death under 40 years-of-age. Or any concomitant medication known to prolong
the QT interval.
- Ejection fraction <50% or the lower limit of normal of the institutional standard
within 28 days prior to randomization.
- Women who are pregnant, nursing, or who plan to become pregnant or nurse during the
trial or within 7 months after the last dose of trial treatment with T-DXd or T-DM1.
Further exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800977373
Email:
italia@bitrialsupport.com
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Japanese Foundation for Cancer Research
Address:
City:
Tokyo, Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Start date:
May 23, 2024
Completion date:
August 21, 2028
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06324357
https://www.mystudywindow.com
