drugset / Trial / NCT07235176

Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients

NCT07235176

Phase 1/2 Recruiting 300 enrolled Qilu Pharmaceutical Co., Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-16
Primary completion
2028-11-02
Completion
2031-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Fulvestrant Small molecule
Subject QLC1401 Unknown
Subject QLS1304 Unknown