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

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Boehringer Ingelheim

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Metastatic Gastric Adenocarcinoma
Esophageal Adenocarcinoma
Metastatic Breast Cancer
Gastroesophageal Junction Adenocarcinoma

Treatments

Drug: Trastuzumab emtansine
Drug: Zongertinib
Drug: Trastuzumab deruxtecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT06324357
1479-0012

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

240 participants in 6 patient groups

Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine
Experimental group
Description:
Dose escalation (Phase Ib)
Treatment:
Drug: Zongertinib
Drug: Trastuzumab emtansine
Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan
Experimental group
Description:
Dose escalation (Phase Ib)
Treatment:
Drug: Trastuzumab deruxtecan
Drug: Zongertinib
Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan
Experimental group
Description:
Dose escalation (Phase Ib)
Treatment:
Drug: Trastuzumab deruxtecan
Drug: Zongertinib
Phase II - Cohort D: zongertinib + Trastuzumab emtansine
Experimental group
Description:
Dose optimization (Phase II).
Treatment:
Drug: Zongertinib
Drug: Trastuzumab emtansine
Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan
Experimental group
Description:
Dose optimization (Phase II).
Treatment:
Drug: Trastuzumab deruxtecan
Drug: Zongertinib
Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan
Experimental group
Description:
Dose optimization (Phase II).
Treatment:
Drug: Trastuzumab deruxtecan
Drug: Zongertinib

Trial contacts and locations

1

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Central trial contact

Boehringer Ingelheim

Data sourced from clinicaltrials.gov

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