ST-01156 for Cancer

This trial tests a new drug, ST-01156, to determine its effectiveness in treating advanced solid tumors, which are cancers that have spread or cannot be surgically removed. The study aims to identify the safest dose by administering the drug once daily for five days, followed by a two-day break. Suitable participants have advanced or metastatic solid tumors and have not recently undergone cancer treatment or surgery. This study is crucial for determining if ST-01156 could become a future treatment option. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

The trial does not specify if you need to stop taking your current medications. However, you cannot have received any anticancer therapy within 14 days before starting the trial.

Research has shown that ST-01156 has been promising in early lab tests conducted before human trials. In these tests, it completely shrank tumors in certain cancers, such as Ewing sarcoma and KRAS mutant colon cancer.

ST-01156 is now in Phase 1 trials, marking its first testing in humans. This phase primarily focuses on assessing the drug's safety and determining the appropriate dose. Detailed safety information from human trials is limited at this stage. However, the FDA's approval to start these trials suggests confidence in its safety based on earlier lab and animal studies.

Unlike standard cancer treatments that often involve chemotherapy or radiation, ST-01156 is unique because it is administered orally and targets cancer cells directly over a short, repeated cycle. This daily dosing for just five days followed by a two-day break is designed to maximize effectiveness while minimizing side effects. Researchers are excited about ST-01156 because it represents a shift toward more targeted cancer therapies, potentially offering a more convenient and less invasive option for patients battling cancer.

Research has shown that ST-01156 produced promising results in early studies. It completely eliminated tumors in certain cancers, such as Ewing sarcoma, neuroblastoma, and a specific type of colon cancer. These findings suggest that ST-01156 might help shrink or remove tumors in these cancers. Although data from human trials remains limited, these early results are encouraging and warrant further exploration of its potential for treating advanced solid tumors. Participants in this trial will receive ST-01156 in a dose escalation format to further investigate its effectiveness and safety.¹²³⁶⁷