Clinical trial 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 testing whether various doses of zongertinib, alone or with other medicines, are safe and can shrink tumors in HER2‑positive cancers that have spread.
- Who it's for
- You may be able to join if you are 18 or older, have HER2‑positive cancer that has spread, and earlier treatments did not work.
- What's involved
- You would take zongertinib, either by itself or with other cancer medicines. You will have regular clinic visits, scans, and safety checks.
- Time commitment
- The study runs for several months with treatment cycles and regular visits to the clinic.
- 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 and P: Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast...
- Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2)...
- For (Phase II): Patient must provide tumor 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, O and P documented investigator...
You likely can't join if
- 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...
- 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...
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 and P: Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal...
- Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression/amplification
- For (Phase II): Patient must provide tumor 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, O and P documented investigator assessed progression
- 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.
- 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 is enrolling
- 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
- 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
- Seattle, Washington, United States
+ 55 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, but 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?
This study is enrolling now at 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 69 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.