Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
NCT ID: NCT07180160
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
123 participants
INTERVENTIONAL
2025-09-25
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QL1706
QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole
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
control
CDK4/6 inhibitor + fulvestrant/letrozole
CDK4/6 inhibitor
palbociclib OR ribociclib OR abemaciclib OR dalpiciclib
Fulvestrant
SERD
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with central nervous system metastasis
18 Years
FEMALE
No
Sponsors
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Wenjin Yin
OTHER
Responsible Party
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Wenjin Yin
Deputy Chief of Breast Surgery Department
Principal Investigators
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Wenjin Yin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Renji Hospital,School of Medicine, Shanghai Jiaotong University
Locations
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Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LY2025-215-C
Identifier Type: -
Identifier Source: org_study_id
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