RecruitingPhase 1Phase 2NCT07235176

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


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

300 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called QLS1304 combined with hormone-blocking (endocrine) therapy in people with a type of breast cancer that is fueled by estrogen (ER+) but does not overexpress the HER2 protein, when the cancer has come back or spread after prior hormone therapy. **You may be eligible if...** - You are 18 or older - You have been confirmed to have ER-positive, HER2-negative breast cancer that has spread or come back - You are in reasonably good health and able to carry out daily activities - At least one prior hormone (endocrine) therapy has not worked for you - You have at least one measurable tumor **You may NOT be eligible if...** - You have never received any endocrine (hormone-blocking) therapy - You have significant organ function problems - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQLS1304 tablet+Fulvestrant or QLC1401

QLS1304 combined with endocrine therapy

DRUGQLS1304 tablet+Fulvestrant,AI or QLC1401+CDK4/6i

QLS1304 combined with endocrine therapy


Locations(1)

Fudan University Cancer Hospital

Shanghai, China

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NCT07235176