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

Condition(s) studied

Investigational drug(s) / intervention(s)

Zongertinib: Zongertinib

Trastuzumab deruxtecan: Trastuzumab deruxtecan

Trastuzumab emtansine: Trastuzumab emtansine

Trastuzumab: Trastuzumab

Capecitabine: Capecitabine

mFOLFOX6: mFOLFOX6 (oxaliplatin, calcium folinate, 5-fluorouracil)

zanidatamab: zanidatamab

Docetaxel: Docetaxel

Study summary

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.

Eligibility

Primary outcome measure(s)

• Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period — up to 21 days
  The MTD evaluation period is defined as the first 21 days of the first treatment cycle for Cohorts A, B, C, G, K, O and P. The MTD evaluation period is defined as the first 28 days after the first administration of any trial medication for Cohorts M and N.
• Dose optimization and justification (Phase II): Objective response (OR) — up to 50 months
  Objective response (OR) is defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review.

Trial sites (104)

+ 64 more sites — see the full list on the official registry below.

On this site

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