Zongertinib: Zongertinib
Trastuzumab deruxtecan: Trastuzumab deruxtecan
Trastuzumab emtansine: Trastuzumab emtansine
Trastuzumab: Herceptin®
Capecitabine: Xeloda®
mFOLFOX6: mFOLFOX6
zanidatamab: zanidatamab
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.
| Facility | City | Region | Status |
|---|---|---|---|
| The Oncology Institute of Hope and Innovation | Cerritos | California | Recruiting |
| Ellison Medical Institute | Los Angeles | California | Not Yet Recruiting |
| Valkyrie Clinical Trials | Los Angeles | California | Recruiting |
| University of California Los Angeles | Los Angeles | California | Recruiting |
| University of California Irvine | Orange | California | Recruiting |
| Sharp Memorial Hospital | San Diego | California | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| Helios CR Inc | Lakeland | Florida | Recruiting |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | Recruiting |
| Orchard Healthcare Research Inc.- Skokie | Skokie | Illinois | Recruiting |
| Community Health Network | Indianapolis | Indiana | Recruiting |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Not Yet Recruiting |
| Memorial Sloan-Kettering Cancer Center | New York | New York | Recruiting |
| New York Cancer & Blood Specialists | Shirley | New York | Recruiting |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | Not Yet Recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | Recruiting |
| Baptist Cancer Center - Memphis | Memphis | Tennessee | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | Recruiting |
| Tennessee Oncology, Pllc | Nashville | Tennessee | Recruiting |
| The Methodist Hospital Research Institute | Houston | Texas | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Not Yet Recruiting |
| Inova Schar Cancer Institute | Fairfax | Virginia | Recruiting |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | Recruiting |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Hôpital Vivalia De Libramont | Libramont-Chevigny | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège | Liège | Belgium | Terminated |
| CHU UCL Namur | Namur | Belgium | Recruiting |
| Jilin Province Cancer Hospital | Changchun | China | Recruiting |
| The First Hospital of Jilin University | Changchun | China | Recruiting |
| Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | China | Recruiting |
| Harbin Medical University Cancer Hospital | Harbin | China | Recruiting |
| Jiangsu Province Hospital | Nanjing | China | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | China | Recruiting |
| Tianjin Cancer Hospital | Tianjin | China | Recruiting |
| Henan Cancer Hospital | Zhengzhou | China | Recruiting |
+ 65 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06324357 on ClinicalTrials.gov ↗ ← All trials in the UK