NCT05963997

A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Carrick Therapeutics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

Detailed description

This is a multiple cohort study, an initial dose escalation phase is designed to confirm the safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee (SRC) will monitor the safety, tolerability, and PK data during this phase. Once ascertained, an expansion cohort will be opened to explore the efficacy of samuraciclib in combination with elacestrant.

Conditions

• Metastatic Breast Cancer
• Locally Advanced Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Samuraciclib	Samuraciclib capsules by mouth once a day
DRUG	Elacestrant Dihydrochloride	Elacestrant tablets by mouth once a day

Timeline

• Start date: 2023-10-09
• Primary completion: 2026-03-06
• Completion: 2026-03-06
• First posted: 2023-07-27
• Last updated: 2026-03-23

Locations

23 sites across 4 countries: United States, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study