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
Wenjin Yin
123 participants
Sep 25, 2025
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
Inclusion Criteria8
- 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 Criteria2
- During pregnancy and lactation
- Patients with central nervous system metastasis
Interventions
QL1706 is a single bifunctional MabPair product consisting of two engineered monoclonal antibodies (anti-PD-1 and anti-CTLA-4).
palbociclib OR ribociclib OR abemaciclib OR dalpiciclib
SERD
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07180160