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)
Facility
City
Region
Status
Renji Hospital, School of Medicine, Shanghai Jiaotong University
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.
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