Table of Contents
- Trial overview
- Cancer types studied
- Trial phases and study goals
- Who can join these studies
- What the trials measure
- Treatment combinations being tested
- Special study in healthy men
Trial overview
The trial data show a group of interventional studies of Zongertinib, also listed in some records as BI 1810631.[1][2] 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.[1][3]
The studies are in different phases, from early dose-finding work to larger trials that compare Zongertinib with standard treatment.[2][3] One completed Phase 1 study also looked at BI 1810631 in healthy men to understand how the body handles the drug.[5]
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.[1] These include breast cancer, gastric cancer, colorectal cancer, gastroesophageal junction adenocarcinoma, and esophageal adenocarcinoma in metastatic form.[2]
Other studies focus on non-small cell lung cancer, including non-squamous disease with HER2 mutations and surgically removed disease with HER2 mutations.[3][4] Another trial includes people with cancer more broadly in an early access setting in Finland.[6]
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.[2] In this trial, the main safety measure is the number of dose-limiting toxicities, or DLTs, during the early treatment period.[2]
The Phase 2 studies look more at anti-tumor activity, which means whether the cancer shrinks or responds to treatment.[1][2] The Phase 3 studies compare Zongertinib with standard treatment and use outcomes such as progression-free survival and disease-free survival.[3][4]
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.[7]
Who can join these studies
Eligibility depends on the specific trial.[1][2] 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.[3][4]
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.[2] The completed Phase 1 study was limited to healthy men.[5]
What the trials measure
Different trials use different main outcomes, called primary endpoints, to judge the study results.[1][2] 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.[1]
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.[2] 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.[3]
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.[4] 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.[7]
Treatment combinations being tested
Some trials test Zongertinib alone, while others combine it with other cancer treatments.[1][2] 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.[2][3][7]
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.[2][3]
Special study in healthy men
One completed Phase 1 study was not in patients with cancer but in healthy men.[5] 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.[5]
This study helps researchers understand how BI 1810631 behaves in the body, which can support later cancer research.[5]
