NCT07180160 Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
| NCT ID | NCT07180160 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Wenjin Yin |
| Condition | Advanced Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 123 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 123 participants in total. It began in 2025-09-25 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Wenjin Yin, M.D.
PRINCIPAL INVESTIGATOR
Renji Hospital,School of Medicine, Shanghai Jiaotong University
Frequently Asked Questions
Who can join the NCT07180160 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Advanced Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07180160 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07180160 currently recruiting?
Yes, NCT07180160 is actively recruiting participants. Contact the research team at yinwenjin@renji.com for enrollment information.
Where is the NCT07180160 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07180160 clinical trial?
NCT07180160 is sponsored by Wenjin Yin. The principal investigator is Wenjin Yin, M.D. at Renji Hospital,School of Medicine, Shanghai Jiaotong University. The trial plans to enroll 123 participants.
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