In short
Clinical trials investigating Siremadlin are studying its use in different patient groups, mainly people with advanced or metastatic cancer and patients in long-term safety follow-up. These trials aim to evaluate safety, treatment activity, and how well the study drug works in selected groups.
Key points
- Siremadlin is being studied in clinical trials for different cancer-related groups and for long-term safety follow-up. One trial is a Phase 3 rollover study focused on safety data, including serious and non-serious adverse events. Another is a Phase 2 study in advanced or metastatic cancer, where researchers are looking at treatment activity in patients with tumor molecular changes. The trials are authorised and include 139 patients in one study and 455 in the other. The main outcomes focus on safety and on whether cancer stays controlled after 3 months of treatment.
Trial overview
The source data includes two authorised clinical trials investigating Siremadlin.
One is an open-label, multi-center, Phase 3 rollover protocol designed to collect long-term safety data. The other is a Phase 2 trial in advanced or metastatic cancer that studies treatment matched to the molecular alterations found in a patient’s tumor.
Who can participate
The Phase 3 rollover study is designed to accept patients with varied disease origins, depending on the parent protocol. In simple terms, this means the exact patient group depends on the earlier study that the person came from.
The Phase 2 study includes people with advanced / metastatic cancers. It also focuses on cohorts based on tumor molecular features, so not every cancer type is treated the same way in the study.
Study phases and design
The rollover safety study is a Phase 3 interventional trial and is open label and multi-center. Open label means both the study team and the patient know what treatment is being given, and multi-center means the trial runs at more than one site.
The cancer-matching study is a Phase 2 interventional trial. Phase 2 studies are usually used to see whether a treatment has activity in a specific group and to continue safety monitoring.
What researchers measure
In the Phase 3 rollover study, the main outcome is the frequency and severity of SAEs/AEs. SAE means serious adverse event, and AE means adverse event; both are unwanted medical problems that happen during a study, but serious events are more severe.
The brief summary says this study is meant to evaluate long-term safety data, especially SAEs and AEs.
In the Phase 2 study, the main outcome is the progression free rate after 3 months of treatment. This means researchers check how many patients have not had their cancer get worse after 12 weeks.
The brief summary for the Phase 2 study says the goal is to evaluate the activity of selected study drugs for each cohort based on molecular alterations or characteristics of the patient’s tumor.
Trial status and size
Both trials are listed as Authorised, meaning they have been approved to run.
The Phase 3 rollover study lists an enrollment of 139 patients. The Phase 2 study lists an enrollment of 455 patients.
The trial data also shows that the Phase 3 study includes treatments such as Jakavi, HDM201, and Farydak in its intervention list. The Phase 2 study lists HDM201 and several other targeted cancer drugs, including alectinib, ribociclib, trametinib, dabrafenib, regorafenib, avapritinib, and cabozantinib.