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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Renji Hospital, School of Medicine, Shanghai Jiaotong University
RECRUITING
Shanghai
Contact Information
Primary
Wenjin Yin, M.D.
yinwenjin@renji.com
86(21)68385569
Time Frame
Start Date: 2025-09-25
Estimated Completion Date: 2028-03
Participants
Target number of participants: 123
Treatments
Experimental: QL1706
QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole
Active_comparator: control
CDK4/6 inhibitor + fulvestrant/letrozole
Related Therapeutic Areas
Sponsors
Leads: Wenjin Yin