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RECRUITING
NCT07235176
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Fudan University Cancer Hospital

Shanghai, China