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This is a single-arm, prospective, Phase II clinical trial designed to assess the efficacy and safety of QL1706 in combination with olaparib in patients with recurrent or metastatic triple-negative breast cancer (TNBC) harboring homologous recombination repair deficiency (HRD) who have received prior therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 + Olaparib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 Plus Olaparib | Drug | QL1706: 5 mg/kg administered via intravenous (IV) infusion every 3 weeks (Q3W). Olaparib: 300 mg (two 150 mg tablets) taken orally twice daily (BID). Treatment will continue until protocol-defined discontinuation criteria are met, including disease progression, unacceptable toxicity, withdrawal of consent, or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) - investigator assessment | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) - Investigator assessment | Up to 2 years | |
| Duration of response (DOR) - Investigator assessment | Up to 2 years | |
| Overall survival (OS) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1% | PFS was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. | Up to 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong-Sheng Tong, MD | Contact | +86 022-23340123 | 2131 | 18622221181@163.com |
| Wei-Peng Zhao, MD | Contact | +86 13662040377 | maoxun1977@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | China |
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|
| Up to 5 years |
| Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) | Up to 5 years |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C531550 | olaparib |
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