In short
Zongertinib is being studied in several clinical trials for different cancers, especially HER2-related tumors and non-small cell lung cancer. These trials look at safety, tolerability, dose finding, and how well the treatment works in people with advanced, metastatic, or surgically removed disease.
Key points
- Zongertinib is being tested in several clinical trials for cancers linked to HER2 changes, especially non-small cell lung cancer and other solid tumors. The studies include Phase 1, Phase 2, and Phase 3 trials, so they cover early dose finding, safety checks, and larger tests of benefit. Some trials study Zongertinib alone, while others combine it with chemotherapy, trastuzumab, pembrolizumab, or other cancer medicines. The main outcomes include objective response, progression-free survival, disease-free survival, and treatment tolerability. The trial data also include a completed study in healthy men that looked at how BI 1810631 is handled by the body.
Trial overview
The trial data show a group of interventional studies of Zongertinib, also listed in some records as BI 1810631. These studies are being done in people with HER2-related cancers, mainly advanced or metastatic disease, and in one case after surgery for non-small cell lung cancer.
The studies are in different phases, from early dose-finding work to larger trials that compare Zongertinib with standard treatment. One completed Phase 1 study also looked at BI 1810631 in healthy men to understand how the body handles the drug.
Cancer types studied
Several trials focus on HER2-mutated or HER2-overexpressed/amplified solid tumours, which means cancers with a HER2 change or too much HER2 activity. These include breast cancer, gastric cancer, colorectal cancer, gastroesophageal junction adenocarcinoma, and esophageal adenocarcinoma in metastatic form.
Other studies focus on non-small cell lung cancer, including non-squamous disease with HER2 mutations and surgically removed disease with HER2 mutations. Another trial includes people with cancer more broadly in an early access setting in Finland.
Trial phases and study goals
The Phase 1 study in metastatic HER2+ cancers is mainly a dose escalation study, which means the researchers look for a dose that can be given safely and may be used in later studies. In this trial, the main safety measure is the number of dose-limiting toxicities, or DLTs, during the early treatment period.
The Phase 2 studies look more at anti-tumor activity, which means whether the cancer shrinks or responds to treatment. The Phase 3 studies compare Zongertinib with standard treatment and use outcomes such as progression-free survival and disease-free survival.
One Phase 2 study in locally advanced or metastatic non-small cell lung cancer looks at whether patients need to stop Zongertinib or have long treatment breaks because of treatment-related side effects in the first two cycles.
Who can join these studies
Eligibility depends on the specific trial. Some studies enroll people with advanced cancer, some require metastatic disease, and the lung cancer Phase 3 studies focus on people with HER2 mutations in non-squamous non-small cell lung cancer or after surgery for non-small cell lung cancer.
The Phase 1 dose-finding study includes different patient groups, such as people with HER2+ metastatic breast cancer, gastric cancer, colorectal cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The completed Phase 1 study was limited to healthy men.
What the trials measure
Different trials use different main outcomes, called primary endpoints, to judge the study results. In the HER2 solid tumor Phase 2 study, the main outcome is the proportion of patients with objective response, meaning the share of patients whose tumors shrink or disappear based on study rules.
In the Phase 1 combination study, the main safety outcome is the occurrence of DLTs during the maximum tolerated dose evaluation period, which is the early time window used to decide whether a dose is too high. In the Phase 3 lung cancer study, the main endpoint is progression-free survival measured by blinded central independent review using RECIST 1.1, a standard method for reading scans and checking tumor size.
In the Phase 3 study after surgery, the main endpoint is disease-free survival, meaning the time from randomization until the cancer comes back or the person dies from any cause. The Phase 2 lung cancer combination study measures whether treatment is stopped or interrupted for more than seven days because of treatment-related adverse events, which are unwanted medical problems linked to treatment.
Treatment combinations being tested
Some trials test Zongertinib alone, while others combine it with other cancer treatments. The Phase 1 and Phase 2 combination studies include treatments such as trastuzumab, trastuzumab deruxtecan, trastuzumab emtansine, capecitabine, mFOLFOX6, zanidatamab, pembrolizumab, pembrolizumab plus platinum-pemetrexed, and other chemotherapy drugs.
These combination studies are trying to find the best dose, the best balance of benefit and safety, and whether adding Zongertinib may improve results compared with standard treatment.
Special study in healthy men
One completed Phase 1 study was not in patients with cancer but in healthy men. It looked at mass balance, total recovery in urine and feces, and bioavailability, which means how much of the drug reaches the bloodstream after oral use compared with intravenous dosing.
This study helps researchers understand how BI 1810631 behaves in the body, which can support later cancer research.