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Samuraciclib

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.

Table of contents

Clinical trial overview

The trial records provided show three completed interventional studies of Samuraciclib in breast cancer.[1][2][3]

All three studies tested Samuraciclib in combination with other medicines, not by itself.[1][2][3]

The research focused on adults with advanced disease, including metastatic and locally advanced breast cancer.[1][3]

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.[1]

Another study included participants with HR+ and HER2- breast cancer, meaning the cancer was hormone receptor-positive and did not have high HER2 levels.[2]

The third study focused on metastatic or locally advanced HR-positive and HER2-negative breast cancer.[3]

These trials were designed for adults, and the source data does not describe pediatric or early-stage breast cancer groups.[1][2][3]

Trial phases and study goals

The studies covered Phase 1 and Phase 2 research.[1][2][3]

Phase 1 work mainly checked safety, tolerability, and dose finding, including the search for a recommended dose for later study.[1][2]

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.[1]

In the elacestrant study, Phase 1b aimed to identify the combination dose for Phase 2 expansion.[2]

Phase 2 research focused more on whether the combinations showed antitumor activity, meaning whether they helped control the cancer.[1][2][3]

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.[1]

That study also measured confirmed tumor response, including complete response and partial response, based on investigator assessment.[1]

It also included a drug-drug interaction assessment, which checked how Samuraciclib and ARV-471 affected each other’s drug levels in the body.[1]

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.[2]

The fulvestrant study measured clinical benefit response, which included complete response, partial response, or stable disease lasting at least 24 weeks after randomization.[3]

Together, these endpoints show that the trials were designed to understand both safety and possible benefit in breast cancer.[1][2][3]

The main Samuraciclib trial programs

NCT06125522 studied Samuraciclib with vepdegestrant in adults with ER+ advanced or metastatic breast cancer.[1]

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.[1]

2023-503846-30-00 studied Samuraciclib with elacestrant in HR+ and HER2-negative breast cancer.[2]

This study included Phase 1b dose finding and Phase 2 expansion, with progression-free survival as a key outcome in the expansion part.[2]

2023-503903-27-00 studied Samuraciclib with fulvestrant in metastatic or locally advanced HR-positive and HER2-negative breast cancer.[3]

This Phase 2 study compared two doses of Samuraciclib and looked at clinical benefit response.[3]

What the trial terms mean for patients

Interventional study means the researchers gave a treatment and watched what happened.[1][2][3]

Enrollment is the number of people who joined the study, and the provided trials enrolled 67, 68, and 60 participants.[1][2][3]

Confirmed response means the tumor shrinkage was checked and verified, not just seen once.[1]

Stable disease means the cancer did not clearly grow or shrink, but stayed controlled for a period of time.[3]

Drug levels in the body help researchers understand how two medicines behave when taken together.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06125522 Phase 1 Advanced or metastatic breast cancer Completed 67
2023-503846-30-00 Phase 1 Breast cancer, HR+ / HER2- Completed 68
2023-503903-27-00 Phase 2 Metastatic or locally advanced HR+ / HER2-negative breast cancer Completed 60

FAQ

  • What is being studied in Samuraciclib clinical trials? The trials are testing Samuraciclib in combination with other cancer medicines. They measure safety, the best dose, and how well the combinations may control breast cancer.
  • Who can join these trials? The studies focus on adults with advanced, metastatic, or locally advanced breast cancer. Several trials specifically include hormone receptor-positive and HER2-negative disease.
  • What trial phases are listed? The trial data includes Phase 1 and Phase 2 studies. Phase 1 studies mainly look at safety and dose finding, while Phase 2 studies look more at how well the treatment works.
  • What results are the trials measuring? The trials measure dose-limiting toxicities, confirmed tumor response, progression-free survival, clinical benefit response, and drug levels in the body. These results help show safety and possible benefit.
  • Are all of the Samuraciclib trials completed? Yes. The trial records provided all show a completed status. They include studies in advanced breast cancer and metastatic or locally advanced hormone receptor-positive, HER2-negative breast cancer.

Ongoing Clinical Trials on Samuraciclib

  • Study on the Safety and Effectiveness of Vepdegestrant and Samuraciclib for Adults with ER+ Advanced or Metastatic Breast Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium France Italy Spain

  • Study of Fulvestrant and Samuraciclib for Patients with Advanced HR Positive, HER2-Negative Breast Cancer

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Hungary Spain

  • Study on the Effects of Samuraciclib and Elacestrant for Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

Glossary

  • Advanced breast cancer: Breast cancer that has grown beyond the original site and is harder to treat than early-stage disease.
  • Metastatic: Cancer that has spread to other parts of the body.
  • Locally advanced: Cancer that has grown more extensively in or around the breast or nearby tissues, but is not described as spread to distant organs.
  • Hormone receptor-positive (HR+): Cancer cells that have receptors for hormones such as estrogen or progesterone, which can help the cancer grow.
  • HER2-negative: Cancer cells that do not have high amounts of the HER2 protein.
  • Phase 1: An early trial phase that mainly checks safety and finds the right dose for a treatment combination.
  • Phase 2: A trial phase that looks more closely at whether a treatment seems to work.
  • Dose-limiting toxicities: Side effects that are serious enough to limit how much of a treatment can be given.
  • Progression-free survival (PFS): The length of time during and after treatment that a cancer does not get worse.
  • Clinical benefit response (CBR): A measure that includes complete response, partial response, or stable disease for a meaningful period.
  • Drug levels in the body: How much of a medicine is present in the blood over time. This helps researchers understand how the medicines behave when used together.

References