In short
Clinical trials are studying Samuraciclib in adults with advanced breast cancer, especially hormone receptor-positive and HER2-negative disease. These studies look at safety, dose finding, and signs of antitumor activity when Samuraciclib is combined with other medicines. They include people with metastatic or locally advanced breast cancer.
Key points
- Clinical trials of Samuraciclib are focused on breast cancer, especially advanced, metastatic, locally advanced, hormone receptor-positive, and HER2-negative disease. The studies include both Phase 1 and Phase 2 research, so they look at safety, dose selection, and early signs of benefit. Samuraciclib is being tested in combination with other medicines such as elacestrant, fulvestrant, and vepdegestrant. The main results include tumor response, progression-free survival, clinical benefit response, and drug levels in the body. All of the trial records provided are completed. The target groups are adults with advanced breast cancer.
Clinical trial overview
The trial records provided show three completed interventional studies of Samuraciclib in breast cancer.
All three studies tested Samuraciclib in combination with other medicines, not by itself.
The research focused on adults with advanced disease, including metastatic and locally advanced breast cancer.
Who these trials studied
One study included adults with ER+ advanced or metastatic breast cancer, which means the cancer had estrogen receptors and had spread or was advanced.
Another study included participants with HR+ and HER2- breast cancer, meaning the cancer was hormone receptor-positive and did not have high HER2 levels.
The third study focused on metastatic or locally advanced HR-positive and HER2-negative breast cancer.
These trials were designed for adults, and the source data does not describe pediatric or early-stage breast cancer groups.
Trial phases and study goals
The studies covered Phase 1 and Phase 2 research.
Phase 1 work mainly checked safety, tolerability, and dose finding, including the search for a recommended dose for later study.
In the umbrella study, Phase 1b was used to assess safety and tolerability of Samuraciclib with vepdegestrant and to select dose levels for the combination.
In the elacestrant study, Phase 1b aimed to identify the combination dose for Phase 2 expansion.
Phase 2 research focused more on whether the combinations showed antitumor activity, meaning whether they helped control the cancer.
What the trials measured
The umbrella study measured dose-limiting toxicities during the first treatment cycle, which are side effects serious enough to limit treatment.
That study also measured confirmed tumor response, including complete response and partial response, based on investigator assessment.
It also included a drug-drug interaction assessment, which checked how Samuraciclib and ARV-471 affected each other’s drug levels in the body.
The elacestrant study measured dose-limiting toxicities, treatment-related side effects, laboratory changes, and progression-free survival, which is the time before the cancer gets worse or the person dies.
The fulvestrant study measured clinical benefit response, which included complete response, partial response, or stable disease lasting at least 24 weeks after randomization.
Together, these endpoints show that the trials were designed to understand both safety and possible benefit in breast cancer.
The main Samuraciclib trial programs
NCT06125522 studied Samuraciclib with vepdegestrant in adults with ER+ advanced or metastatic breast cancer.
This study had a Phase 1b part for safety and dose selection, a Phase 2 part for antitumor activity, and extra cohorts for drug interaction testing.
2023-503846-30-00 studied Samuraciclib with elacestrant in HR+ and HER2-negative breast cancer.
This study included Phase 1b dose finding and Phase 2 expansion, with progression-free survival as a key outcome in the expansion part.
2023-503903-27-00 studied Samuraciclib with fulvestrant in metastatic or locally advanced HR-positive and HER2-negative breast cancer.
This Phase 2 study compared two doses of Samuraciclib and looked at clinical benefit response.
What the trial terms mean for patients
Interventional study means the researchers gave a treatment and watched what happened.
Enrollment is the number of people who joined the study, and the provided trials enrolled 67, 68, and 60 participants.
Confirmed response means the tumor shrinkage was checked and verified, not just seen once.
Stable disease means the cancer did not clearly grow or shrink, but stayed controlled for a period of time.
Drug levels in the body help researchers understand how two medicines behave when taken together.