NCT07235176

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced ER+/HER2- Breast Cancer

Interventions

Type	Name	Description
DRUG	QLS1304 tablet+Fulvestrant or QLC1401	QLS1304 combined with endocrine therapy
DRUG	QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i	QLS1304 combined with endocrine therapy

Timeline

• Start date: 2026-01-05
• Primary completion: 2028-11-02
• Completion: 2031-12-30
• First posted: 2025-11-19
• Last updated: 2026-01-12

Locations

1 site across 1 country: China