In short
Clinical trials are studying Setanaxib in people with recurrent or metastatic head and neck squamous cell carcinoma and in people with Alport syndrome. These studies are looking at safety, tolerability, and early signs of benefit. They also measure changes in tumor size and treatment-related safety outcomes.
Key points
- Two completed Phase 2 trials investigated Setanaxib in very different patient groups. One study focused on recurrent or metastatic squamous cell carcinoma of the head and neck and compared Setanaxib plus pembrolizumab with placebo plus pembrolizumab. The main cancer endpoint was the best percentage change in tumor size using RECIST v1.1, a standard tumor-measuring system. The other study enrolled people with Alport syndrome and looked mainly at safety and tolerability. It also measured serious adverse events and treatment-emergent anemia-related safety findings. Together, these trials show that Setanaxib has been studied in both cancer and a rare kidney disease.
Trial overview
Two interventional studies investigated Setanaxib, which means the researchers assigned study treatment and then measured the results. Both studies were in Phase 2, a stage that looks for early signs of benefit while continuing safety checks. Both trials were listed as completed.
Recurrent or metastatic head and neck cancer study
The first study, NCT05323656, was titled as a research study to investigate the safety of Setanaxib and helpfulness in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). This means it studied a cancer that had come back or spread to other parts of the body.
This trial compared Setanaxib plus pembrolizumab with placebo plus pembrolizumab. A placebo is an inactive treatment that looks like the study medicine, so researchers can better compare results. The study enrolled 48 patients.
The main goal was to compare change in tumor size using RECIST v1.1, which is a standard way to measure how tumors change over time. The primary outcome was the best percentage change in the sum of target lesion diameters from baseline, which means the researchers looked for the biggest shrinkage or change from the starting scan.
Alport syndrome study
The second study, NCT06274489, was a Phase 2a study in patients with Alport syndrome. Alport syndrome is a rare inherited disease that can affect the kidneys and may also affect hearing and vision.
This study compared Setanaxib with placebo tablets. It enrolled 34 patients. The brief summary says the study aimed to evaluate the safety and tolerability of Setanaxib compared with placebo in patients with Alport syndrome.
The main safety outcomes were the percentage of patients with serious adverse events and the percentage of patients with treatment-emergent adverse events of special interest, which in this study included anemia. Anemia means a low number of red blood cells or low hemoglobin, which can make a person feel tired or weak.
What the trials measured
In the cancer study, the key endpoint was tumor response measured by the best percentage change in tumor size from baseline. This kind of endpoint helps show whether the cancer got smaller, stayed the same, or grew during treatment.
In the Alport syndrome study, the key endpoints were safety-related measures, especially serious adverse events and treatment-emergent anemia-related events. These outcomes help researchers understand whether the treatment can be given safely in this patient group.
Who the studies were designed for
The cancer trial was designed for patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The Alport syndrome trial was designed for patients with Alport syndrome. These are very different groups, which shows that Setanaxib was studied in both an advanced cancer setting and a rare kidney disease setting.
Trial status and size
Both studies were completed, so the planned treatment and outcome collection were finished. The cancer study enrolled 48 people, and the Alport syndrome study enrolled 34 people. These trial sizes are typical of early Phase 2 research, where the goal is to learn more about whether a treatment may help and how safe it is in a defined patient group.