Table of contents
- Trial overview
- Cancer types and target populations
- Trial phases and what they mean
- Treatment combinations being tested
- Main endpoints and study goals
- Who can join these studies
- Study designs and comparison groups
Trial overview
These trials study Zanidatamab in people with different cancers, most often cancers that are HER2-positive or HER2-expressing.[1] The studies include both single-drug and combination-treatment research, and they are looking at whether the treatment can control cancer better than other options or help define the best dose for future use.[1][2]
The trial list includes studies that are already authorised, and one study that is completed.[1] The research is being done in several settings, such as advanced disease, metastatic disease, and unresectable disease, which means the cancer cannot be removed by surgery.[1][3]
Cancer types and target populations
The largest groups in the trial data are people with gastroesophageal adenocarcinoma, gastric and esophageal cancers, biliary tract cancer, and breast cancer.[1][2][3] Some studies also include broader groups such as HER2-expressing solid tumors and selected solid cancers with HER2 changes, including endometrial, colorectal, head and neck, sarcoma, and HER2-mutant non-small cell lung cancer.[4]
Several studies focus on people whose cancer is HER2-positive, which means the tumor has a high amount of the HER2 protein or a HER2 gene change.[1][4] One study also focuses on HER2 and PD-L1 positive metastatic gastroesophageal adenocarcinoma, so it is looking at a narrower group with two tumor features.[2]
Trial phases and what they mean
The studies in the data range from Phase 1 to Phase 3.[1][2][3] Phase 1 studies usually focus on dose, safety, and early signs of activity, while Phase 2 and Phase 3 studies look more closely at how well the treatment works and compare it with other treatment plans.[5][6]
One Phase 1 study in HER2-positive advanced breast cancer is designed to find the maximum tolerated dose, or MTD, and the recommended phase 2 dose, or RP2D.[7] This means the trial is trying to learn how much treatment can be given safely and what dose should be taken forward for later testing.[7]
Treatment combinations being tested
Many trials do not test Zanidatamab alone.[1][2][3] Instead, it is studied with chemotherapy, and in some studies it is paired with other cancer medicines such as pembrolizumab, tislelizumab, tucatinib, palbociclib, fulvestrant, or chemotherapy drugs like capecitabine, oxaliplatin, gemcitabine, cisplatin, paclitaxel, docetaxel, eribulin, and carboplatin.[1][2][3][4]
Some trials compare a Zanidatamab-based plan with a treatment that uses trastuzumab, which is another HER2-targeted cancer medicine named in the study records.[1][8] Other studies compare several treatment arms, meaning different groups receive different combinations so researchers can see which plan performs best.[7]
Main endpoints and study goals
The main endpoint in many studies is progression-free survival, or PFS, which measures how long patients live without the cancer getting worse.[1][2][3] Some studies measure PFS at a set time point, such as 12 months or 24 weeks, while others measure PFS using standard scan rules like RECIST 1.1.[2][7]
Other important endpoints include overall survival, which is how long patients live after starting treatment, and objective response rate, which is the percentage of patients whose tumors shrink enough to count as a response.[1][4][8] One breast cancer study also measures pathologic complete response, which means no cancer is found in the tissue removed after treatment, based on the pathologist’s review.[9]
The completed breast cancer study also looked closely at safety and tolerability.[9] Its safety checks included dose-limiting toxicities, serious adverse events, lab changes, ECG changes, and left ventricular ejection fraction changes, which are heart function measurements.[9]
Who can join these studies
Eligibility depends on the study, but most trials are for adults with advanced, metastatic, or unresectable cancer.[1][3] Some studies require HER2 positivity, and some also need PD-L1 positivity or HER2 overexpression, such as IHC 3+ results.[2][4]
Some studies are limited to people who have not yet received treatment for their metastatic disease, while others include people with previously treated cancer or several treatment lines.[2][1] Because each trial has its own rules, the target population can be quite different from one study to another.[1][4]
Study designs and comparison groups
Most of the studies are interventional, meaning the researchers assign a treatment plan and then measure the results.[1][2][3] Several are randomized and open-label, which means participants are placed into study groups by chance and both the researchers and participants know which treatment is being given.[3][8]
The Phase 3 studies are especially important because they compare Zanidatamab-based treatment with other standard treatment plans such as trastuzumab-based therapy or chemotherapy-based regimens.[1][3][8] These studies aim to show whether the Zanidatamab strategy can improve cancer control in the studied patient groups.[1][2][3]
