clinical trial · NCT07235176
Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
Qilu Pharmaceutical Co., Ltd.·phase2·recruiting·n = 300
Advanced ER+/HER2- Breast CancerQLS1304 tablet+Fulvestrant or QLC1401QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i
brief 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.
started
Jan 5, 2026
primary completion
Nov 2, 2028
completion
Dec 30, 2031
last updated
Jan 12, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol