NCT05293964

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

A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Efficacy of SIM0270 Alone or in Combination in Subjects with ER-positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is comprised of two parts: Phase Ia and Phase Ib. Phase Ia includes dose-escalating stage and dose expansion stageof SIM0270 monotherapy to determine the MTD/ RP2D and the preliminary safety and efficacy of SIM0270; Phase Ib includes 2 arms, armA: dose escalation and dose expansion of SIM0270 in combination with palbociclib; armB: dose escalation and dose expansion of SIM0270 in combination with palbociclib everolimus; phase Ib is designed to determine the MTD/RP2D and the preliminary safety and efficacy of SIM0270 in combination with palbociclib or everolimus.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	SIM0270	SIM0270 is an oral, selective estrogen receptor degrader (SERD)
DRUG	Palbociclib	palbociclib is a selective inhibitor of cyclin D-cyclin-dependent kinase (CDK) 4/6
DRUG	everolimus	Everolimus is an inhibitor of mTOR (mammalian target of rapamycin)

Timeline

• Start date: 2022-05-18
• Primary completion: 2024-12-31
• Completion: 2025-09-08
• First posted: 2022-03-24
• Last updated: 2024-11-29

Locations

1 site across 1 country: China