In short
Lsta1 is being studied in clinical trials for people with newly diagnosed glioblastoma multiforme and for adults with advanced solid tumors such as head and neck cancer and cholangiocarcinoma. These trials are looking at safety, survival, and side effects when Lsta1 is added to standard treatment. Both studies are Phase 2 interventional trials.
Key points
- Lsta1 is being studied in two Phase 2 clinical trials. One trial looks at newly diagnosed glioblastoma multiforme and compares Lsta1 plus temozolomide with temozolomide-based control treatment. The other trial studied adults with advanced solid tumors, including head and neck cancer and cholangiocarcinoma. The main goals are to check survival in glioblastoma and to assess safety in advanced solid tumors. One study is authorised, and the other has been completed. Together, these trials focus on whether Lsta1 may help in cancer treatment and how safe it is when added to standard therapy.
Trial overview
Clinical trials of Lsta1 are studying it in cancer settings, not as a general medicine description. The available trial data include one study in newly diagnosed glioblastoma multiforme and one Phase 2a basket trial in advanced solid tumors, including head and neck cancer and cholangiocarcinoma.
Both studies are interventional, which means the researchers gave study treatments and then measured the results.
Study in newly diagnosed glioblastoma multiforme
The first study is titled “LSTA1 for subjects with newly diagnosed Glioblastoma Multiforme when added to standard of care (temozolomide) versus temozolomide.” It is a Phase 2 study with 40 planned participants and is listed as authorised.
This study is for people with newly diagnosed glioblastoma multiforme, which is a fast-growing brain tumor.
The study compares Lsta1 plus temozolomide against a matching placebo plus temozolomide. A placebo is an inactive treatment used for comparison, so researchers can better understand whether the study drug makes a difference.
The main goal is to see whether adding Lsta1 changes overall survival, which means how long people live after randomization, regardless of the cause of death.
Phase 2a basket trial in advanced solid tumors
The second study is called “LSTA1 Phase 2a basket trial in advanced solid tumors.” It is a Phase 2 study, has 80 planned participants, and is listed as completed.
This study included adults with advanced solid tumors, with conditions listed as head and neck cancer and cholangiocarcinoma.
A basket trial is a study that looks at one treatment in more than one cancer type, so researchers can study the same approach across different groups of patients.
The treatment groups included Lsta1 with several standard therapies, and comparison groups that used placebo with standard therapies. The listed study drugs included gemcitabine, durvalumab, cisplatin, and paclitaxel, depending on the treatment group.
The main goal was to evaluate the safety of Lsta1 in combination with standard of care therapies compared with standard of care alone.
Who the trials were for and how people were treated
The glioblastoma study focused on people with newly diagnosed disease, meaning the cancer had been found recently.
The basket trial focused on adults with advanced cancers, including head and neck cancer and cholangiocarcinoma.
In the glioblastoma study, Lsta1 was given together with temozolomide, while the comparison group received placebo with temozolomide.
In the basket trial, Lsta1 was studied together with different standard cancer treatments, and the trial also included placebo groups for comparison.
What the trials measured
An endpoint is the main result a trial is designed to measure.
For the glioblastoma study, the primary endpoint was overall survival, measured from randomization until death from any cause.
For the basket trial, the primary endpoint was the incidence and severity of adverse events, which means how often unwanted medical problems happened and how serious they were.
Study status and size
The glioblastoma study is listed as authorised and planned to enroll 40 people.
The advanced solid tumor basket trial is listed as completed and planned to enroll 80 people.
These two studies together show that Lsta1 is being explored in different cancer settings, with one study focused on survival in brain cancer and the other focused on safety across advanced solid tumors.