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Recruiting Phase 2

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

NCT07180160 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Phase 2
Started
2025-09-25
Last updated
2025-11-18

Condition(s) studied

Advanced Breast Cancer

Investigational drug(s) / intervention(s)

QL1706 →CDK4/6 inhibitorFulvestrant →

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

CDK4/6 inhibitor: palbociclib OR ribociclib OR abemaciclib OR dalpiciclib

Fulvestrant: SERD

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Female, age≥18 years old * Expected survival ≥12 weeks * ECOG 0-1 * Pathologically confirmed recurrent or metastatic breast cancer not amenable to curative surgery * ER and/or PR positive, HER2 negative * At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1 * Previously treated with ≤2 lines chemotherapy for advanced disease; previously treated with ≤2 CDK4/6 inhibitors * Adequate organ function Exclusion Criteria: * During pregnancy and lactation * Patients with central nervous system metastasis

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — From the date of starting study treatment to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)
    PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07180160 on ClinicalTrials.gov ↗ ← All trials in China