RecruitingPhase 2NCT07180160

Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer

Iparomlimab and Tuvonralimab (QL1706) in Patients With Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial


Sponsor

Wenjin Yin

Enrollment

123 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — iparomlimab and tuvonralimab (together called QL1706) — in women with hormone receptor-positive, HER2-negative breast cancer that has come back or spread, and is no longer responding well to standard hormone therapies. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative - Your cancer has measurable areas on imaging - You have received no more than two prior chemotherapy regimens and no more than two CDK4/6 inhibitor treatments for advanced disease - You have a good performance status (ECOG 0-1) **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your cancer has spread to the brain - You have severe organ function problems 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

DRUGQL1706

QL1706 is a single bifunctional MabPair product consisting of two engineered monoclonal antibodies (anti-PD-1 and anti-CTLA-4).

DRUGCDK4/6 inhibitor

palbociclib OR ribociclib OR abemaciclib OR dalpiciclib

DRUGFulvestrant

SERD


Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

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NCT07180160


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