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

Breast Cancer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05963997
Study type Interventional
Source Carrick Therapeutics Limited
Contact Clinical Operations
Phone +353 1 5996873
Email hello@carricktherapeutics.com
Status Recruiting
Phase Phase 1/Phase 2
Start date October 9, 2023
Completion date June 16, 2025
View Details
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