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 (NCT06324357)
Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)
🩺 Plain-English Summary (8th-Grade Level)
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), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow. In this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups 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 other treatments. 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.
Who can join: Review the eligibility criteria below.
Location: The Oncology Institute of Hope and Innovation — Cerritos, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (105 Sites)
Showing the first 25 of 105 sites.
- The Oncology Institute of Hope and Innovation — Cerritos, California
- Ellison Medical Institute — Los Angeles, California
- Valkyrie Clinical Trials — Los Angeles, California
- University of California Los Angeles — Los Angeles, California
- University of California Irvine — Orange, California
- Sharp Memorial Hospital — San Diego, California
- Yale University School of Medicine — New Haven, Connecticut
- Helios CR Inc — Lakeland, Florida
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
- Orchard Healthcare Research Inc.- Skokie — Skokie, Illinois
- Community Health Network — Indianapolis, Indiana
- University of Iowa Hospitals and Clinics — Iowa City, Iowa
- Dana-Farber Cancer Institute — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Memorial Sloan-Kettering Cancer Center — New York, New York
- New York Cancer & Blood Specialists — Shirley, New York
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania
- Avera Cancer Institute — Sioux Falls, South Dakota
- Baptist Cancer Center - Memphis — Memphis, Tennessee
- SCRI Oncology Partners — Nashville, Tennessee
- Tennessee Oncology, Pllc — Nashville, Tennessee
- The Methodist Hospital Research Institute — Houston, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- Inova Schar Cancer Institute — Fairfax, Virginia
- Virginia Cancer Specialists, PC — Fairfax, Virginia
📞 Contact the Study Coordinator
Phone: (800) 243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Breast Cancer
- Assessing the Time Demands of Cancer — Birmingham, Alabama
- Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer — Birmingham, Alabama
- A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer — Commack, New York
- Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor — Washington D.C., District of Columbia
- A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer — Tucson, Arizona
- Roll-over Study to Allow Continued Access to Ribociclib — Chandler, Arizona
Explore by condition: All Metastatic Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.