Clinical Trial

Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer

Active, Not Recruiting Phase 1
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Record status
This record was last updated November 29, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
Summary
This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen receptor (ER) -positive, human epidermal growth factor receptor (HER-2) -negative locally advanced or metastatic breast cancer.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-03-14; most recent amendment 2024-11-26.
Status change: Recruiting → Active, Not Recruiting 2024-11-26
Status change: Not Yet Recruiting → Recruiting 2022-05-18
Trial Details
NCT Number NCT05293964
Lead Sponsor Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators: Nanjing Zaiming Pharmaceutical Co., Ltd.
Conditions Breast Cancer
Enrollment 214 participants
Start Date 2022-05-18
Primary Completion 2024-12-31 (estimated)
Study Completion 2025-09-08 (estimated)
Updated on ClinicalTrials.gov 2024-11-29