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New treatment option for Metastatic Breast Cancer
Official 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
ClinicalTrials.gov ID: NCT06324357
What this study is testing
What is Zongertinib?
Zongertinib is an investigational medicine, being studied as a potential treatment for metastatic breast cancer.
Also referred to as BI 1810631, Hernexeos®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Cohorts A to K and Cohort O: Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast cancer...
- Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2)...
- For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible...
- History of prior treatment lines in palliative setting:
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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 apply.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cerritos, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Diego, California, United States
- New Haven, Connecticut, United States
- Lakeland, Florida, United States
- Tampa, Florida, United States
- Skokie, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Shirley, New York, United States
- Hershey, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
+ 61 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cerritos, California, United States; Los Angeles, California, United States; Orange, California, United States; San Diego, California, United States; New Haven, Connecticut, United States; Lakeland, Florida, United States and 75 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.