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

NCT05293964 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2024-11-29

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Nanjing Zaiming Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jiong Wu, phD · chief physician

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2024-12-31
Completion
2025-09-08

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293964 on ClinicalTrials.gov