SIM0270

DRUG4 trials

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

Conditions

Breast CancerHealthy Adult ParticipantsHealthy ParticipantsLocally Advanced or Metastatic Breast Cancer

Phase 1

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

Active, not recruitingNCT05293964

Jiangsu Simcere Pharmaceutical Co., Ltd.Breast Cancer

Start: 2022-05-18End: 2025-09-08Updated: 2024-11-29

Evaluate the Effects of Food on the Pharmacokinetics of SIM0270

CompletedNCT06536036

Jiangsu Simcere Pharmaceutical Co., Ltd.Healthy Participants

Start: 2024-07-23End: 2024-10-16Updated: 2024-12-02

An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants

RecruitingNCT07357610

Jiangsu Simcere Pharmaceutical Co., Ltd.Healthy Adult Participants

Start: 2026-01-05End: 2026-10-30Target: 60Updated: 2026-01-22

Phase 3

A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

RecruitingNCT06680921

Jiangsu Simcere Pharmaceutical Co., Ltd.Locally Advanced or Metastatic Breast Cancer

Start: 2024-11-14End: 2028-08-31Target: 460Updated: 2025-09-22

Related Papers

Abstract PS14-03: Updated analyses from a Phase I study of the brain-penetrant oral SERD- SIM0270 in patients with ER-positive,HER2-negative advanced breast cancer

Clinical Cancer Research2025-06-13

Abstract PS14-04: SIM0270, a brain-penetrant oral SERD, in combination with everolimus in patients with ER+/HER2- advanced breast cancer: the phase Ib study

Clinical Cancer Research2025-06-13

SIM0270 in combination with palbociclib in patients with ER+/ HER2- advanced breast cancer: The phase Ib study.

Journal of Clinical Oncology2025-05-28

SIMRISE: A randomized phase III trial evaluating SIM0270 in combination with everolimus versus treatment of physician’s choice in patients with ER+/HER2- advanced breast cancer, previously treated with CDK4/6 inhibitors.

Journal of Clinical Oncology2025-05-28

Abstract PS15-01: A first-in-human phase 1 study of SIM0270, a brain-penetrant oral selective estrogen receptor degrader (SERD), in patients with ER+/HER2- locally advanced or metastatic breast cancer

Cancer Research2024-05-021 citations