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Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast cancer patients. This study was divided into two stages: combo dose escalation and dose expansion.
Official title: A Phase Ib/II Clinical Study to Evaluate Safety, Preliminary Efficacy and PK Characteristic of QLS1304 Combined With Endocrine Therapy in ER+/HER2- Breast Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-01-05
Completion Date
2031-12-30
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
QLS1304 tablet+Fulvestrant or QLC1401
QLS1304 combined with endocrine therapy
QLS1304 tablet+Fulvestrant,AI or QLC1401+CDK4/6i
QLS1304 combined with endocrine therapy
Locations (1)
Fudan University Cancer Hospital
Shanghai, China