1479‑0012, Zongertinib for HER2+ mBC and mGEAC
Research type
Research Study
Full title
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) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC)
IRAS ID
1011679
Contact name
CT Disclosure & Data Transparency
Contact email
Sponsor organisation
Boehringer Ingelheim Pharma GmbH
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing a new medication, zongertinib (BI 1810631) (trial medication), to treat people with advanced (locally advanced & metastatic) cancers. “Locally advanced” cancers have grown outside of the body part where it started but not yet spread to other parts of the body. Locally advanced cancers can also be difficult to treat, e.g., because of their size or location. “Metastatic” cancers have spread to other parts of the body.
The advanced cancers included in this trial are HER2+ of breast and stomach cancer. HER2 (human epidermal growth factor receptor 2) is a protein with molecules at the surface of advanced cancers. HER2 sends a signal to cancer cells to grow and multiply uncontrollably.
The purpose of this trial is to learn more about how the trial medication works for people with advanced breast or stomach cancer, when given alone or in combination with other approved anti-cancer medications, i.e., T-DXd, or T-DM1, or trastuzumab with or without capecitabine. The trial will also look at how the body processes the trial medication (“pharmacokinetics” or PK) and whether the trial medication has an effect on cancer growth.
The trial consists of 2 parts. Part A of the trial is designed to evaluate different doses of the trial medication, combined with anti-cancer medications. This is called “dose escalation”. The purpose of dose escalation is to find the highest dose of the trial medication that is safe and does not cause side effects. Part B of the trial is designed to further assess the trial medication, alone or combined with anti-cancer medications. This is called “dose optimisation”. The purpose of dose optimisation is to assist in the selection of optimal dose for further clinical development.
Approximately 594 people will take part globally.
Both Parts A and B consist of Screening period (up to 28 days), Treatment period (21-day cycles), and Post-Treatment period follow-up until disease progression, start of new treatment or death.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0138
Date of REC Opinion
21 Aug 2025
REC opinion
Further Information Favourable Opinion