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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

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